MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDDRA500Q

Device Problem Migration (4003)

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

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

Further information was requested, but not received.

Event Description

Related manufacturer reference number: 2017865-2022-38790.Related manufacturer reference number: 2017865-2022-38792.It was reported that a patient presented in-clinic.Upon examination, the patient's right atrial (ra) lead was found to have exhibited high capture thresholds and a drop in sensing.The right ventricular lead exhibited loss of capture and decreased sensing.Both the ra and rv leads were determined to have dislodged due to the electrical issues and was confirmed with x-ray imaging during the revision procedure to address the leads, the patient's implantable cardioverter defibrillator (icd) was found to have migrated.The physician suspected twiddler's syndrome as the cause of both lead dislodgements and the icd migration.The ra lead was repositioned and the rv lead was explanted and replaced on (b)(6) 2022.No intervention was reported to address the icd migration.The patient was stable and no patient consequences were reported.

Manufacturer Narrative

Additional information: h6: field should reflect intervention for device.

Event Description

New information received notes that the physician suspects that the patient physically manipulated the device, causing it to flip.The device was successfully repositioned and anchored down on (b)(6) 20222 during the procedure and is still in use.

• Brand Name: GALLANT DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 15459654
• MDR Text Key: 300370691
• Report Number: 2017865-2022-38794
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: P000129942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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