Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Check against the official notice below — it lists the full affected range.
Medtronic has recalled approximately 5,392 dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta, Versa, and Sensia. The affected devices are Sphera DR MRI SureScan models SPDR01 and SPDRL1. These pacemakers may experience a circuit error when programmed to dual chamber mode with atrial-sensing that could affect how the device functions.
The recall applies to all serial numbers of the affected models. The source does not specify a remedy for consumers with these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Reason for recall: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality Distribution: Wordlwide Quantity: 5392 units Lot/code info: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.