MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7170/65

Device Problems Break (1069); High impedance (1291); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital for a follow-up on (b)(6) 2022.Upon examination of the lead, it was noted that the right ventricular (rv) lead failed to pace and had high pacing lead impedance.Physician visually confirmed insulation damages about 1 cm away from proximal end of the rv coil.The rv lead was explanted and replaced on (b)(6) 2022.The patient was in stable condition.

Manufacturer Narrative

The reported events of high pacing lead impedance, pacing failure and insulation damage were confirmed.As received, a partial lead was returned in three pieces.Lead insulation was verified to be damaged between the shock coils consistent with procedural damage which is the cause of the insulation damage that was reported in the field.Visual and x-ray examinations of the lead found that the inner coil and one ring electrode cable were found broken/fractured distal to the suture sleeve tie impression.Sem analysis was performed and verified that all filars of the inner coil was fractured.The cause of the reported events of high pacing lead impedance and pacing failure was due to the fractured inner coil and ring electrode cable consistent with fatigue fracture.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13867358
• MDR Text Key: 287779833
• Report Number: 2017865-2022-06129
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502436
• UDI-Public: 05414734502436
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P950022
• 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
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2012
• Device Model Number: 7170/65
• Device Catalogue Number: 7170-65
• Device Lot Number: 2913493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2009
• 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
• Treatment: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Patient Outcome(s): Required Intervention