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

Model Number	5480
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a clinic follow up, a decrease in the device battery longevity was observed and possible premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
The customer complaint of premature depletion was not confirmed.The device was received for analysis in backup mode.Device image analysis shows that backup mode occurred after device was explanted which is consistent with exposure to low temperatures after explant.Additional device image analysis indicated that the device was used in high output mode and the autocapture feature was used at times.When automatic settings are programmed, such as autocapture, the device output adjusts itself to accommodate the patient¿s needs for pacing, and thus affects the estimated longevity of the device.The original battery had depleted to eol levels due to normal usage.Analysis performed after installing a new battery and reloading the product code including functional testing, did not reveal any anomalies.The device was implanted for 6.93 years, which exceeded the device¿s 6.86 year projected longevity and is considered normal battery depletion.

• Brand Name: IDENTITY ADX VDR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9613344
• Report Number: 2017865-2020-00731
• Device Sequence Number: 2677760
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 06/30/2014
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: 3890630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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: Hospitalization; Required Intervention