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

Model Number 7122/65

Device Problems Failure to Capture (1081); Failure to Sense (1559)

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

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that during follow up in clinic post implant, it was observed that the right ventricular (rv) lead's parameters were out of range.There was no capture at high outputs and no r waves were detected.Fluoroscopy noted the lead was in position in the rv apex.Multiple programming options such as changing to unipolar mode were attempted but the issue was not resolved.The physician decided to open the pocket and check the rv lead's position and found the rv lead to be properly screwed and inserted into the device port but no pacing or sensing was observed.The rv lead was explanted and replaced.All parameters were stable with the new lead.The patient was stable.

Manufacturer Narrative

The reported events of no capture and failure to sense were not confirmed.A complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures.Internal shorts due to procedural damage to the insulation was found.Visual inspection of the lead found no anomalies with the exception of damages consistent with procedural damage.

Manufacturer Narrative

Correction section h6: the investigation conclusions code should have been " 67 - no problem detected " instead of "4315 - cause not established".

• 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: 12025906
• MDR Text Key: 257162855
• Report Number: 2017865-2021-23003
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• Combination Product (y/n): Y
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: A000103005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 09/23/2021
• Supplement Dates FDA Received: 09/27/2021; 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention