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

Model Number 5386

Device Problems Difficult to Interrogate (1331); Telemetry Discrepancy (1629)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that during a follow up, interrogation of the pulse generator was difficult.When attempting to perform tests, loss of telemetry occurred.In between testing, there were no telemetry issues.Despite changing programmers and repositioning the telemetry wand, the issue remained.The device was explanted and replaced.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Final analysis found that the pulse generator exhibited intermittent telemetry due to a discrepant integrated circuit.

• Brand Name: IDENTITY ADX XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407 ; 4684744043
• MDR Report Key: 4902840
• MDR Text Key: 6067213
• Report Number: 3010215456-2015-27954
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2004
• Device Model Number: 5386
• Device Lot Number: 0002346510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2003
• 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
• Patient Outcome(s): Required Intervention