MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CRMD ISOFLEX LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1944/52

Device Problem Difficult to Advance (2920)

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

Event Date 12/19/2011

Event Type  malfunction  

Event Description

It was reported that the lead was unable to implant.Grating of the lead observed during introducer insertion.

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 unable to implant lead was confirmed.A style could not be advanced through the lead due to inner coil offset.The cause of offset inner coil could not be determined.

• Brand Name: ISOFLEX LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4192032
• MDR Text Key: 4963923
• Report Number: 2017865-2014-04670
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 08/31/2014
• Device Model Number: 1944/52
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/19/2011
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/19/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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