MAUDE Adverse Event Report: ABBOTT CRM IDENTITY ADX; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5380
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
During follow-up, backup vvi was noted on the device.Technical support was contacted and it is unknown whether premature battery depletion or normal eri was the cause of the backup vvi.The device is awaiting explant and replacement to resolve the event.The patient was in stable condition.
Event or Problem Description
The device was explanted and replaced to resolve the event of backup vvi.The patient was in stable condition.
Additional Manufacturer Narrative
The customer complaint of bvvi was confirmed.The device was received in bvvi settings and output was lower than expected due to low battery level.The device image analysis showed that bvvi occurred due to transient voltage fluctuations which occurred due to hardware code corruption.The original battery had depleted to normal eol level.The analysis performed after installing a new battery and reloading the product code did not find any anomalies.The implant duration was 11.55 years, which exceeded 10.37 year projected longevity and is considered normal battery depletion.Despite extensive testing backup condition could not be reproduced and the cause of code corruption could not be determined.

• Brand Name: IDENTITY ADX
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT CRM; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8660736
• Report Number: 2017865-2019-08980
• Device Sequence Number: 19407895
• Product Code: LWP
• UDI-Device Identifier: 05414734006897
• UDI-Public: 05414734006897
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2019

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: 01/31/2009
• Device Model Number: 5380
• Device Lot Number: 2949459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/10/2019; 11/13/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/12/2019; 11/15/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR