MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q/58

Device Problems Failure to Capture (1081); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

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

Event Date 08/07/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-40438.It was reported that in (b)(6) 2023, the right atrial (ra) lead was found to be dislodged during a follow-up clinic visit.Both leads were not able to sense or pace.When the patient presented for a revision, x-ray was performed, and both the ra and right ventricular (rv) leads were dislodged and twisted around each other.Both leads were extracted, and new ra and rv leads were implanted.There were no adverse health consequences, the patient was stable.

Manufacturer Narrative

The reported events of lead dislodgment, failure to capture, and failure to sense were not confirmed.As received, a complete lead was returned in one piece with the helix fully extended and clogged blood/tissue.The helix extension was within specification.Electrical testing did not find any indication of conductor fracture or internal shorts.Visual and x-ray examination of the lead did not find any anomalies.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17633699
• MDR Text Key: 322086216
• Report Number: 2017865-2023-40439
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• 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
• Report Date: 09/14/2023

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 Model Number: 7122Q/58
• Device Lot Number: A000137318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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: GALLANT ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White