MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40C

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 06/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced a fall that caused trauma to the implantable cardioverter defibrillator (icd) area.The right ventricular lead developed a fracture due to the fall and exhibited noise.The patient subsequently experienced multiple episodes of inappropriate shock caused by the right ventricular lead noise.On (b)(6) 2019, the right ventricular lead was capped and replaced along with the icd.During the procedure, it was also noted that the atrial lead had insulation damage and exhibited noise.The physician repaired the atrial lead with a suture sleeve and adhesive but the lead still exhibited noise.The physician elected to not replace the atrial lead at this time and concluded the procedure.The patient condition was stable.Related manufacturer reference number: 2017865-2019-09928, 2017865-2019-09929.

Manufacturer Narrative

The reported field event of inappropriate hv therapies was confirmed in the laboratory due to review of the stored egms.Noise was observed on the ventricular channel which caused the inappropriate therapies, and it was reported that the patient had a fall which might have fractured the lead.The device was tested on the bench using automated testing equipment and no anomalies were found.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8725236
• MDR Text Key: 148906267
• Report Number: 2017865-2019-09927
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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: 07/31/2020
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000062718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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: RIATA ST; TENDRIL DX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR