MAUDE Adverse Event Report: ST. JUDE MEDICAL, CRMD TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/52

Device Problems Break (1069); Low impedance (2285)

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

Event Date 05/06/2011

Event Type  malfunction  

Event Description

It was reported that during implant the lead exhibited low impedance and insulation anomaly.The lead was explanted.

Manufacturer Narrative

This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.The reported field event of insulation anomaly was confirmed in laboratory.The damage found was that of a crush that has happened during implant.It has resulted in electrical short which confirm low lead impedance noted in field.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4192015
• MDR Text Key: 4963918
• Report Number: 2017865-2014-04617
• Device Sequence Number: 1
• Product Code: DTS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: 2088TC/52
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/06/2011
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/19/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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 Age: 41 YR