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

Model Number	5157M/S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2019
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 in clinic for a routine follow up, pocket infection was observed.The primary and secondary cause of infection was unknown.The device was explanted.There is no known allegation from the health care professional that the infection was related to the device or procedure.The patient was stable post procedure.
Additional Manufacturer Narrative
Implant date should have been (b)(6) 2013 instead of (b)(6) 2013 and it's corrected in follow up report.
Additional Manufacturer Narrative
Analysis was normal.No anomalies found.

• Brand Name: ADX XL DR
• 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: 8269354
• Report Number: 2938836-2019-00475
• Device Sequence Number: 1697236
• Product Code: LWP
• UDI-Device Identifier: 05414734006774
• UDI-Public: 05414734006774
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 5157M/S
• Device Lot Number: 3776044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 02/18/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/26/2019; 03/04/2019
• 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: 68 YR