MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1258T/86

Device Problems Break (1069); Insufficient Information (3190)

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

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for an explant procedure.The left ventricular (lv) lead was explanted and replaced due to unknown reasons.The patient condition was unknown.

Manufacturer Narrative

Further information was requested but not received.

Event Description

New information received notes that the left ventricular (lv) lead was explanted and replaced due to the lead was damaged during extraction of the right ventricular lead.The patient was in a stable condition.

Manufacturer Narrative

The reported event of material integrity problem was confirmed.As received, a complete lead was returned in two pieces.Visual examination found multiple insulation abrasions the first one breaching the ring electrode lumen, the second one breaching the inner coil lumen exposing the inner coil consistent with friction to the device can, the third one breaching the ring electrode lumen consistent with friction to another device or feature of patient¿s anatomy, the fourth one was an internal abrasion breaching the ring electrode lumen the etfe coating was intact in these abraded regions.The cause of the reported events was isolated to the abrasions found.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 16001704
• MDR Text Key: 305681164
• Report Number: 2017865-2022-48905
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

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 Expiration Date: 06/30/2013
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: 3146385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/18/2022
• Supplement Dates Manufacturer Received: 12/29/2022; 01/05/2023
• Supplement Dates FDA Received: 12/29/2022; 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2010
• 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
• Treatment: DURATA SVC LEAD; RIGHT ATRIAL LEAD; UNIFY ASSURA ICD
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 58 KG