MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI OPTISENSE; PERMANENT PACEMAKER ELECTRODE

Model Number 1999/46

Device Problems Over-Sensing (1438); High Capture Threshold (3266)

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

Event Date 11/03/2011

Event Type  malfunction  

Event Description

It was reported that the lead exhibited high pacing threshold and noise.The lead has not implanted.

Manufacturer Narrative

All info provided by mfr, 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.The reported field event of high threshold and noise was not confirmed.Analysis was normal.No anomaly was found.

• Brand Name: OPTISENSE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4212702
• MDR Text Key: 5036311
• Report Number: 2017865-2014-05117
• Device Sequence Number: 1
• Product Code: DTS
• 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: 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: 07/31/2014
• Device Model Number: 1999/46
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/03/2011
• Device Age: 4 MO
• Date Manufacturer Received: 11/03/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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: 58 YR