MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5376
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented for a generator change due to the elective replacement indicator (eri).During interrogation, it was noted that the device was in backup vvi mode.The device was believed to have reached battery depletion eri which may have contributed to the backup vvi.There were no patient consequences as a result of the backup vvi.The device was explanted and replaced.The patient was stable before, during and after the procedure.
Additional Manufacturer Narrative
The reported event of pacemaker found in back-up mode was confirmed.As received, device had no telemetry and no output due to low battery voltage.Device image analysis showed that bvvi occurred due to multi-byte memory corruption, and this is consistent with combo ic anomaly.Actions have been taken to prevent reoccurrence.The original battery had depleted to end of life (eol) level.Analysis performed after installed new battery and reloaded product code, did not find any anomalies.Longevity assessment was performed, device¿s implanted duration exceeded projected longevity and is considered normal battery depletion.

• Brand Name: IDENTITY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8906628
• Report Number: 2017865-2019-12530
• Device Sequence Number: 17067896
• Product Code: DXY
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2007
• Device Model Number: 5376
• Device Catalogue Number: 5376
• Device Lot Number: 0002283421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR