MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; No Match

Model Number CDVRA500Q

Device Problem Migration (4003)

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

Event Date 08/16/2023

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 2017865-2023-42320.It was reported by the patient that the right ventricular lead exhibited inappropriate shock.Upon review of transmission, it was found that the right ventricular (rv) lead exhibited inappropriate shock due to t-wave over-sensing.It was also found that the rv lead exhibited r-wave amplitude variation, low lead impedance, and high capture threshold.It was believed that the patient had twiddler's syndrome as the implantable cardioverter defibrillator (icd) was found to be migrated.The rv lead was explanted and replaced, and the icd was repositioned during the same procedure on (b)(6) 2023.The patient was discharged home in good condition.

• Brand Name: GALLANT VR
• Type of Device: No Match
• 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: 17695592
• MDR Text Key: 322799342
• Report Number: 2017865-2023-42321
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: 05415067031990
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDVRA500Q
• Device Lot Number: P000174146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female