MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7120Q/58

Device Problems Premature Elective Replacement Indicator (1483); Low impedance (2285)

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

Event Date 01/10/2014

Event Type  Injury  

Event Description

It was reported that when the patient presented to the hospital for an unrelated procedure, low, out of range, hv lead impedance was observed.The lead remains implanted and will be revised when patient recovers from a previous surgery.

Manufacturer Narrative

External insulation abrasion was noted at 10.9-11.3cm from the connector pin, consistent with lead friction to the icd can.The rv conductor etfe coating was abraded and melted at this location.This is consistent with the observation from the field of low hv lead impedance.The reported field events of oversensing and noise were not confirmed in the laboratory.

Event Description

New information received indicated that the lead was explanted.Noise, oversensing and an insulation anomaly were also observed.The patient was in good, stable condition after the event.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• 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 ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3656352
• MDR Text Key: 4355638
• Report Number: 2938836-2014-07548
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 7120Q/58
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2014
• Device Age: 44 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2010
• 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
• Patient Age: 66 YR