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 Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2017865-2021-28749.Related manufacturer reference number: 2017865-2021-28750.It was reported that the patient presented to the hospital for a follow-up.During examination, it was noted that the parylene coating on the implantable cardioverter defibrillator (icd) was becoming detached from the device.It was also observed that the right ventricular (rv) lead had insulation deterioration due to which noise was observed.Further examination revealed that the left ventricular (lv) lead had increasing capture threshold and low pacing lead impedance which was compared to impedance taken in 2016.The physician capped and replaced the rv lead and the lv lead on (b)(6) 2021.The icd was explanted and replaced as well the patient was inn stable condition.

Manufacturer Narrative

The parylene coating detachment from device that was observed in the field was confirmed in the laboratory.Parylene delamination was observed on the can.The parylene coating gradually delaminated while implanted and was noted at explant; this behavior is consistent with handling during the implant procedure which contributed to the parylene delamination.Correction d9 - date returned to manufacturer changed from aug 16, 2021 to aug 10, 2021.

Manufacturer Narrative

Correction h6- changed medical device problem code to peeled/delaminated.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12354414
• MDR Text Key: 267698547
• Report Number: 2017865-2021-28754
• 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: 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,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: 4843003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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: QUICKSITE; RIATA; QUICKSITE; RIATA
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 97 KG