MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5480
Medical Device Problem Codes	Premature Discharge of Battery (1057); No Device Output (1435)
Health Effect - Clinical Codes	Bradycardia (1751); Fatigue (1849)
Date of Event	02/09/2020
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
Related manufacturer reference number: 2017865-2020- 03521.It was reported that patient presented to follow up on (b)(6) 2020 with his own junctional rhythm and experiencing fatigue.Upon interrogation, the pacemaker exhibited no pacing on electrograms.The battery longevity had significantly dropped since last follow up on (b)(6) 2019, premature battery depletion was suspected.The device was explanted and replaced.On (b)(6) 2020, during the procedure, the right ventricular lead exhibited high impedance and failure to capture in bipolar configuration.The lead was reprogrammed to unipolar configuration.Patient was stable during and after the procedure.
Additional Manufacturer Narrative
Interrogation of the device revealed the device was at eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Based on this information, there was no evidence of premature depletion.

• Brand Name: IDENTITY ADX VDR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9869510
• Report Number: 2017865-2020-03139
• Device Sequence Number: 2877778
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 06/24/2020

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: 04/30/2013
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: 3531252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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: AV PLUS DX BIFUR BIPOLAR LEAD
• Outcome Attributed to Adverse Event: Required Intervention