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

Model Number 5376

Device Problem Programming Issue (3014)

Patient Problem Discomfort (2330)

Event Date 05/10/2018

Event Type  malfunction  

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 Description

It was reported that the patient experiencing discomfort presented in the hospital for routine device change-out procedure.The physician wanted to program the patient's pacemaker before replacing it; the device could not be reprogrammed.The physician replaced the old device without programming.The cause of the event was unknown, it was suspected that this could have been due to electromagnetic interference.The patient was in stable condition.

Manufacturer Narrative

The reported field event of programming anomaly was confirmed in the laboratory.The device was tested on the bench and no anomalies were found.Correction: the initial report type should be "serious injury" instead of "malfunction".

• Brand Name: IDENTITY XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7584580
• MDR Text Key: 110574718
• Report Number: 2017865-2018-08448
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2007
• Device Model Number: 5376
• Device Lot Number: 3033341
• Other Device ID Number: 05414734006880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1