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

Model Number 1888TC/58

Device Problems Positioning Failure (1158); Capturing Problem (2891); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during implant of the right ventricular lead, acceptable capture and sensing values could not be obtained.During repositioning, the lead's helix would not retract.The lead was removed from the pocket and replaced.Upon removal, foreign material was observed in the helix of the lead.

• Brand Name: TENDRIL ST
• 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: 5072043
• MDR Text Key: 25660787
• Report Number: 2017865-2015-28383
• 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: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 1888TC/58
• Device Lot Number: 4711784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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