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

Model Number 2088TC/58

Device Problem Over-Sensing (1438)

Patient Problem Dizziness (2194)

Event Date 01/02/2013

Event Type  Injury  

Event Description

It was reported that the right ventricular lead exhibited noise with oversensing.Lead remained implanted.

Event Description

New information indicates the lead continued to exhibit noise.The lead was capped and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.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.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.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.Correction: model should be 2088tc/58 rather than 1888tc/58 and serial should be (b)(4) rather than (b)(4).

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE, DTS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CMRD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4054578
• MDR Text Key: 4901340
• Report Number: 2017865-2014-09142
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: 2088TC/58
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/02/2013
• Event Location: Hospital
• Date Manufacturer Received: 01/02/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2010
• 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