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

Model Number 2088TC/52

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/04/2016

Event Type  Injury  

Manufacturer Narrative

The field reports of low lead impedance and noise were confirmed.As received, a complete lead was returned in one piece.Internal insulation abrasion was noted at 21.5cm from the connector pin.The inner insulation was found to be breached at this location.This is consistent with the observation from the field of low lead impedance and noise.(b)(4).

Event Description

It was reported that the patient presented after receiving a vibratory alert for low impedance and noise on the atrial lead.The lead was explanted and replaced successfully.No additional information as available.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6303947
• MDR Text Key: 66596164
• Report Number: 2017865-2017-00783
• 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
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 2088TC/52
• Device Lot Number: P000017329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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: 46 YR