MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 2938836-2019-06088, 2938836-2019-06089.It was reported that during a routine follow up, the device was found to be in back up mode.The patient was asymptomatic.During the procedure, both the ra and rv leads were found to have had an insulation breach at the suture sleeve site.The leads were capped and replaced on (b)(6) 2019.The device was explanted and replaced.The patient was stable before, during, and post procedure.
Additional Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed.The device was tested on the bench and found backup operation was consistent with end of life battery voltage.Longevity assessment was performed, and the implant duration exceeds the total projected longevity based on field settings indicating normal battery depletion.Analysis was normal.No anomalies were found.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• 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: 8859775
• Report Number: 2938836-2019-06086
• Device Sequence Number: 1812158
• Product Code: DXY
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 03/31/2009
• Device Model Number: 5366
• Device Lot Number: 0002120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL SDX; TENDRIL SDX
• Outcome Attributed to Adverse Event: Required Intervention