Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Check against the official notice below — it lists the full affected range.
Medtronic is recalling approximately 10,006 units of the Model B35200 Percept PC BrainSense Implantable Neurostimulator worldwide, including distribution throughout the United States, Puerto Rico, and numerous other countries. The device can become unresponsive and non-functional during cardioversion procedures, which are medical procedures performed by cardiologists to correct abnormal heartbeats. Medtronic determined that the electrical energy from cardioversion can damage the circuit electronics inside the neurostimulator, rendering it non-responsive.
The affected devices are identified by specific serial numbers beginning with "NPI" followed by numbers and the letter "H." The recall notice does not specify any remedy or corrective action that consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
Reason for recall: During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive. Distribution: Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina, Braz Quantity: 10,006 units Lot/code info: GTIN 00763000253363, Serial Numbers: NPI714835H, NPI714811H, NPI714812H, NPI714814H, NPI714816H, NPI714817H, NPI714819H, NPI714820H, NPI714750H, NPI714764H, NPI714771H, NPI714794H, NPI714682H, NPI714709H, NPI714710H, NPI714594H, NPI714598H, NPI714599H, NPI714602H, NPI714603H, NPI714606H, NPI714564H, NPI714572H, NPI714574H, NPI714587H, NPI714588H, NPI714589H, NPI714373H, NPI714379H, NPI714331H, NPI714346H, NPI714358H, NPI714378H, NPI714128H, NPI714160H, NPI714060H, NPI713947H, NPI713956H, NPI713957H, NPI714001H, NPI714017H, NPI713948H, NPI713949H, NPI713951H, NPI713952H, NPI713953H, NPI713954H, NPI713955H, NPI713829H, NPI713371H, NPI713372H, NPI713422H, NPI713242H, NPI713188H, NPI712940H, NPI712785H, NPI712637H, NPI712405H, NPI712411H, NPI712412H, NPI712341H, NPI712302H, NPI712256H, NPI711876H, NPI711841H, NPI711475H, NPI711476H, NPI710876H, NPI710765H, NPI710561H, NPI710071H, NPI709964H, NPI709680H, NPI709654H, NPI709655H, NPI709575H, NPI708692H, NPI708699H, NPI708702H, NPI708709H, NPI708675H, NPI708653H, NPI708635H, NPI708457H, NPI708415H, NPI708417H, NPI708425H, NPI708367H, NPI708376H, NPI708358H, NPI708316H, NPI708288H, NPI708289H, NPI708292H, NPI708295H, NPI708299H, NPI708300H, NPI708305H, NPI708306H, NPI708309H, NPI708258H, NPI708262H, NPI708273H, NPI708127H, NPI708128H, NPI708153H, NPI708101H, NPI708102H, NPI708103H, NPI708106H, NPI708107H, NPI708110H, NPI708112H, NPI708113H, NPI708114H, NPI708117H, NPI708118H, NPI708120H, NPI708121H, NPI708123H, NPI708124H, NPI708125H,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.