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

Model Number	CD3257-40
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Related manufacturer report number: 2017865-2020-04623.It was reported that the patient presented for a routine generator replacement.The patient was programmed voo before the older implantable cardioverter defibrillator (icd) model 3257 was disconnected.Bovie was used by the physician in the pocket resulting in true loss of capture and asystole.Telemetry showed pacing outputs were consistent with voo.The leads were switched to the new icd model 3357 and electrocautery resulted in a similar asystole with telemetry showing pacing.Programming changes to increase output were made.All changes resulted in asystole despite pacing.The physician opted to proceed with the implant since the issue occurred across both generators and seemed only related to the electrocautery (bovie) in the pocket and not to the device itself.The asystole only lasted as long as the bovie bursts ~ 2-3 seconds.The patient had no adverse effects, was stable and no intervention was needed.Voo* - (asynchronous pacing mode - pacing delivered at a fixed rate with no sensing to prevent noise detection by electrocautery during procedure).
Additional Manufacturer Narrative
The reported field event of loss of capture was confirmed through electrocardiogram (egm) review; functional test results indicated normal device behavior.Stored electrocardiogram (segm's) review revealed oversensing and loss of capture as a result of noise external to the device; this noise was determined to be cautery.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: UNIFY ASSURA ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9922384
• Report Number: 2017865-2020-04622
• Device Sequence Number: 11601752
• Product Code: NIK
• UDI-Device Identifier: 05414734505628
• UDI-Public: 05414734505628
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 4008508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNIFY ASSURA CRT-D RF HV; UNIFY ASSURA CRT-D RF HV
• Patient Age: 80 YR