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

Model Number 7120/60

Device Problems Break (1069); Low Sensing Threshold (2575); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (2114)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2020-11560.It was reported that the patient presented for a routine generator change.Upon interrogation, it was noted that the implantable cardioverter defibrillator exhibited low r-wave sensing on the right ventricular lead.It was noted that the patient had occasionally twiddled with their device and moved the device in the pocket.During the procedure, it was noted that the right ventricular lead had pulled back and there was outer insulation damage due to the lead rubbing against the device.The low r-waves was believed to be due to the device pulling back the lead when it was moved in the pocket.The device and lead were explanted and replaced.Patient was stable.

Manufacturer Narrative

The partial connector portion of the lead measuring 18.4 cm was returned.The reported event of insulation abrasion was confirmed.Visual examination found two external insulation abrasions located distal to the trifurcation boot consistent with friction to the device can.Visual and x-ray examination did not find any other anomalies with the exception of procedural damage.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10415977
• MDR Text Key: 203277957
• Report Number: 2017865-2020-11562
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502085
• UDI-Public: 05414734502085
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: 7120/60
• Device Catalogue Number: 7120-60
• Device Lot Number: 2776887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CURRENT PLUS VR
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 87