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

Model Number	5376
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2938836-2019-04599.It was reported an asymptomatic patient presented in clinic for a follow up, when interrogation failed while testing was being performed, and the session ended abruptly.The device was explanted and replaced on (b)(6) 2019.The atrial lead was also capped and replaced on the same day due to low impedance.The patient was stable throughout.
Additional Manufacturer Narrative
Additional information: the reported field event of telemetry anomalies was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

• Brand Name: IDENTITY 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: 8681419
• Report Number: 2938836-2019-04598
• Device Sequence Number: 3020117
• Product Code: LWP
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: 5376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 06/09/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 63 YR
• Patient Weight: 60