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

Model Number 1948/58

Device Problem Difficult to Advance (2920)

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

Event Date 05/20/2014

Event Type  malfunction  

Event Description

It was reported that during implant the lead exhibited an anomaly.The lead was not used and replaced.

Manufacturer Narrative

Analysis found normal device characteristics.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3923480
• MDR Text Key: 4521102
• Report Number: 2017865-2014-14756
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: NA
• 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,Followup

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: 08/31/2016
• Device Model Number: 1948/58
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 07/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• 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