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

Model Number 1999/52

Device Problems Failure to Capture (1081); Difficult to Advance (2920)

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

Event Date 02/29/2012

Event Type  malfunction  

Event Description

It was reported that the lead exhibited capture anomaly and stylet could not be inserted during implant.The lead was not implanted.

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.Eval description: the reported field event of capture anomaly was confirmed in the laboratory and was due to short circuit caused by damaged inner insulation.The damage of inner insulation was a result of over torque of inner coil and the reason for preventing the styler insertion.Initial reporter: company rep.

• Brand Name: OPTISENSE
• 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: 4084087
• MDR Text Key: 4896798
• Report Number: 2017865-2014-07900
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 1999/52
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2012
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/27/2012
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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