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

Model Number CDDRA500Q

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Migration (4003)

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

Event Date 10/20/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-44376, related manufacturer reference number: 2017865-2022-44379.It was reported the patient presented to the emergency room due to diaphragmatic stimulation.X-ray confirmed the atrial and right ventricular leads had dislodged due to twiddlers syndrome.The atrial and right ventricular leads were successfully repositioned on (b)(6) 2022.The patient was seen for follow-up and the atrial and right ventricular leads exhibited a failure to sense and failure to capture.X-ray showed the implantable cardioverter defibrillator (icd) had migrated minimally and the atrial and right ventricular leads dislodged due to twiddlers syndrome a second time.The atrial and right ventricular leads were explanted and replaced.When attempting to connect the new leads, the set screw would not tighten and the pacing impedance was high.The icd was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of set screw issue and high pacing impedance was confirmed while the event of migration was not confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.Analysis revealed the right ventricular set screw was dislodged, stripped, and contained septum material inside the hex cavity.This material inside the hex cavity prevented full insertion of the torque driver.Additionally, septum material was found at the bottom of the right ventricular connector block and inside the lead bore.The septum material inside the lead bore prevented full insertion of the lead into the bore which resulted in high impedance measurements.The set screw anomaly was consistent with having occurred during the procedure.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16219634
• MDR Text Key: 307876137
• Report Number: 2017865-2023-02811
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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: 02/16/2023

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: 04/30/2024
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000086525
• 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: 01/12/2023
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 84 KG