MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VERITY ADX XL VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5456I
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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
During follow-up, an incorrect battery impedance measurement was observed on the device.Technical support was contacted and recommended reprogramming, which was performed in order to resolve the event.The patient was stable and there were no adverse consequences.

• Brand Name: VERITY ADX XL VDR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7599197
• Report Number: 2017865-2018-08762
• Device Sequence Number: 11059494
• Product Code: LWP
• UDI-Device Identifier: 05414734010474
• UDI-Public: 05414734010474
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: 5456I
• Device Lot Number: 3619812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1