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

Model Number	5480
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled pacemaker change procedure.Upon examination, the device was unable to be interrogated.The physician did not allege that there was premature battery depletion.The device was then explanted and replaced successfully.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Correction: h6 results code "474 - ic (integrated circuit)" should had been included in the previous follow up report for device evaluation.
Additional Manufacturer Narrative
The pacer was received with battery voltage at eri.The device was cut open and in-circuit battery voltage was measured to be at eri level.Longevity assessment was performed, device¿s implanted duration exceeded projected longevity and is considered normal battery depletion.Additional testing was performed with new battery to verify functionality of the telemetry by reducing the battery voltage level.Test results indicated loss of telemetry when battery voltage dropped below 2.18 v.Combo ic (u2) was identified as the cause of the telemetry issue.

• 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: 10245603
• Report Number: 2017865-2020-08791
• Device Sequence Number: 16968318
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020

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: 12/31/2014
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: 4140421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 10/29/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 10/26/2020; 10/29/2020
• 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