MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SENSIA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	SEDR01
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: 5554-53 lead implanted: (b)(6) 1999.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the device was noted to have an estimated 21 months of remaining longevity.Approximately six months later, the estimated longevity had decreased to 6 months.After another approximately two months, the device had reached recommended replacement time (rrt), whereupon the patient became symptomatic due to the switch to vvi pacing mode.The device was explanted and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Evaluation summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENSIA DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7982447
• Report Number: 3004209178-2018-23429
• Device Sequence Number: 16518795
• Product Code: NVZ
• UDI-Device Identifier: 00613994177957
• UDI-Public: 00613994177957
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/14/2009
• Device Model Number: SEDR01
• Device Catalogue Number: SEDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5054-58 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR