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Recall Observatory FDA recall evidence

Device product

Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

Z-0810-2019

January 17, 2019

Class I

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 81945
Status
Ongoing
Classification
Class I
Quantity
5392 units
Official record key
device-enforcement:Z-0810-2019

Official wording

Reason: 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

Code information: 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

Distribution pattern: Wordlwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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