MAUDE Adverse Event Report: ABBOTT SUSTAIN XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1136
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
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 follow-up in clinic, the device had reached elective replacement indicator (eri) sooner than expected.Premature battery depletion was alleged.The device was explanted and replaced, and the patient was stable with no consequences.
Additional Manufacturer Narrative
As-received, the device was at elective replacement indicator (eri).The device was then programmed to nominal settings for the remainder of the analysis.The results of all electrical testing performed, including thermal and mechanical stress testing, indicated normal device characteristics.A longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.Review of the device image revealed that the eri alert was false, as the monthly battery trend data during the implant period shows that the battery voltage has not reached eri level.The device image also indicated that the device was operating in high output mode (hom) at times as a result of the autocapture feature.The device output was automatically adjusted to accommodate the patient¿s needs for pacing, thus affecting the estimated remaining longevity of the device and triggering the false eri alert.The reported event of premature battery depletion could not be confirmed.

• Brand Name: SUSTAIN XL SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10148452
• Report Number: 2017865-2020-07067
• Device Sequence Number: 16594247
• Product Code: NVZ
• UDI-Device Identifier: 05414734504737
• UDI-Public: 05414734504737
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 10/31/2014
• Device Model Number: PM1136
• Device Catalogue Number: PM1136
• Device Lot Number: 4059325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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