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

Model Number 1156T/75

Device Problems Low impedance (2285); Naturally Worn (2988)

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

Event Date 11/29/2021

Event Type  Injury  

Event Description

Related manufacturer's reference number: 2017865-2021-39532.It was reported that the patient presented for a procedure.During the procedure, it was discovered that the right atrial lead had an insulation damage.It was also noted that the right ventricular lead was exhibiting low pacing impedance, and after the lead was extracted externalized conductors were observed.The physician opted to explant the entire system; and successfully implanted a new system.The patient was in stable condition.

• Brand Name: QUICKFLEX 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13026760
• MDR Text Key: 282408423
• Report Number: 2017865-2021-39534
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 1156T/75
• Device Lot Number: 0002653224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2008
• 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 STS OPTIM ACTIVE FIXATION; DURATA STS OPTIM ACTIVE FIXATION; UNIFY ASSURA CRT-D RF HV
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female