MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5056
Medical Device Problem Codes	Premature Discharge of Battery (1057); Pacemaker Found in Back-Up Mode (1440); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Discomfort (2330)
Date of Event	10/23/2020
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
It was reported that the patient presented for follow up in clinic due to diaphragmatic stimulation on the device.The patient was feeling unwell.The device was found to be in backup vvi.Premature battery depletion was noted.The device was explanted and replaced.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.The device was received in back up mode due to low battery voltage from normal usage.Analysis performed after installing a known good battery and reloading product code indicated that the device exhibited normal device characteristics with no anomalies.Longevity assessment was performed, the implant duration exceeded the device¿s projected longevity and device is considered as normal battery depletion.The reported complaint of premature battery depletion was not confirmed.

• Brand Name: VERITY ADX XL
• 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: 10800189
• Report Number: 2938836-2020-09141
• Device Sequence Number: 16960675
• Product Code: DXY
• UDI-Device Identifier: 05414734006712
• UDI-Public: 05414734006712
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 07/31/2016
• Device Model Number: 5056
• Device Catalogue Number: 5056
• Device Lot Number: P000000282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 02/10/2021
• 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
• Patient Age: 78 YR