MAUDE Adverse Event Report: ABBOTT 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Suspected premature battery depletion on the device was noted.The device was explanted and replaced.The patient was stable with no adverse consequences.
Additional Manufacturer Narrative
The field complaint of premature depletion could not be confirmed.The device was received at elective replacement battery voltage.Analysis of the device image found no battery trend data anomalies.Autocapture had been enabled with occurrences in high output mode, and, as stated in the device manual, programming to high output settings may shorten the time to elective replacement indicator trigger.Device interrogation revealed no high current.Longevity assessment was performed, and total projected longevity exceeds the majority of the implant duration based on field settings indicating normal battery depletion.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8744394
• Report Number: 2017865-2019-10245
• Device Sequence Number: 2358339
• Product Code: LWP
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2019

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: 08/31/2007
• Device Model Number: 5366
• Device Lot Number: 3025413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 09/23/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/26/2019; 09/23/2019
• 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