MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/52

Device Problems Over-Sensing (1438); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

Final analysis found that the insulation was abraded at 7.0-7.4cm,7.6-7.8cm,8.0-8.3cm,8.5-8.9cm from the connector pin.The abrasions were consistent with exposure to constant friction against another implantable device or feature of the heart.Other damages found on the lead are consistent with that occurring at the time of explant.(b)(4).

Event Description

It was reported that the right atrial lead exhibited noise during arm manipulation.During lead revision, blood was observed under the insulation.The lead was explanted and replaced.The patient was in stable condition.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 5069394
• MDR Text Key: 25480036
• Report Number: 2017865-2015-28341
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/10/2015

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: 01/31/2017
• Device Model Number: 2088TC/52
• Device Lot Number: 4410848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• 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: 49 YR
• Patient Weight: 50