MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problem Failure to Disconnect (2541)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-46673.Related manufacturer reference number: 2017865-2023-46674.Related manufacturer reference number: 2017865-2023-46675.It was reported that the patient presented in the emergency room upon receiving inappropriate high voltage (hv) therapy from their right ventricular (rv) lead.The patient complained of diaphragmatic stimulation.It was found that the shocks were due to noise over-sensing by the rv lead.Loss of capture and loss of sensing were also noted on the rv lead.Noise was additionally noted on the atrial lead.X-ray confirmed dislodgement of both the atrial and rv leads, along with slight pulling back of the left ventricular (lv) lead.During lead revision procedure, it was found that all of the leads were entangled and knotted around the device can, consistent with having been caused by twiddler's syndrome.The rv and lv leads and the device can were removed and replaced, and the atrial lead was removed without replacement.The patient was stable.

Manufacturer Narrative

The reported field event of lead connection issue was not confirmed.Upon receipt, the device was above elective replacement indicator (eri).Final analysis found no anomalies.

• Brand Name: GALLANT HF
• 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: 17790013
• MDR Text Key: 323945182
• Report Number: 2017865-2023-46672
• Device Sequence Number: 1
• Product Code: NIK
• 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: 11/14/2023

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 Model Number: CDHFA500Q
• Device Lot Number: A000137980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 11/11/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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 Age: 84 YR
• Patient Sex: Female
• Patient Weight: 99 KG