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

Model Number 5376

Device Problems Pacemaker Found in Back-Up Mode (1440); Loss of Data (2903)

Patient Problem Palpitations (2467)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during follow-up, the pulse generator was found to be operating in backup vvi mode.The patient was experiencing palpitations.Interrogation was possible but data could not be obtained.Device restoration was unsuccessful.It was explanted and replaced on (b)(6) 2015.The patient was noted to be in good condition following the procedure.

• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5421682
• MDR Text Key: 37837128
• Report Number: 2017865-2016-00205
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2008
• Device Model Number: 5376
• Device Lot Number: 0002189281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR