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

Model Number	5376
Medical Device Problem Codes	Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
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 appeared to be in afib between 80-90 bpm and no pacing.After trying several methods to interrogate the device, it was unable to gain telemetry.Patient will be scheduled for follow-up.
Event or Problem Description
New information notes that the patient was recently seen by the following physician.It was discussed by the physician and the patient to probably not changing the device out at this time.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
New information notes that on (b)(6) 2019, the device was explanted at normal eri.
Additional Manufacturer Narrative
The reported failure to interrogate and no pacing was confirmed.As received, device had no telemetry and no output due to low battery voltage.Analysis performed after installed new battery and reloaded product code, including output measurement, did not find any anomalies.The original battery was depleted to eol level.The implant duration exceeded the device¿s projected longevity and considered normal battery depletion.

• Brand Name: IDENTITY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9200356
• Report Number: 2938836-2019-15235
• Device Sequence Number: 3654645
• Product Code: DXY
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2020

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: Health Professional
• Device Expiration Date: 10/31/2006
• Device Model Number: 5376
• Device Catalogue Number: 5376
• Device Lot Number: 0002295032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 10/22/2019; 05/08/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 10/22/2019; 02/03/2020; 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR