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

Model Number	5380
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
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
It was reported that the patient presented in the operating room for a routine device change.During the procedure, it was noted that the right ventricular lead could not be removed from the header.The lead was capped and replaced on (b)(6) 2018.The patient was stable.
Additional Manufacturer Narrative
Correction: the device was explanted and replaced.
Event or Problem Description
Correction: the device was explanted and replaced.
Additional Manufacturer Narrative
The damage found was sustained during the surgical procedure.The device was otherwise normal.

• Brand Name: IDENTITY ADX
• 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: 8026850
• Report Number: 2938836-2018-11876
• Device Sequence Number: 11036138
• Product Code: LWP
• UDI-Device Identifier: 05414734006897
• UDI-Public: 05414734006897
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2019

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: 11/30/2012
• Device Model Number: 5380
• Device Lot Number: 3396991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/29/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/10/2018; 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR