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

Model Number	CD3257-40
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.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 reference number: 2017865-2020-14099.Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.Prior to the procedure, using fluoroscopy, the physician noted externalized conductors on the patient's right ventricular (rv) lead.The rv lead was explanted and replaced.The patient was stable throughout.
Additional Manufacturer Narrative
The reported field event of bpa was verified in the lab.Further investigation showed the bpa was a false positive.Prior to the event, device had a reset, which cleared the device¿s usage data.The bpa algorithm uses device usage history data for calculations, and since that data got cleared after reset, a false bpa was triggered.This is normal and expected behavior when the data is cleared.Interrogation of the device revealed the device was above eri when received.No other anomaly was detected.

• 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: 10575011
• Report Number: 2017865-2020-14098
• Device Sequence Number: 11717078
• Product Code: NIK
• UDI-Device Identifier: 05414734505628
• UDI-Public: 05414734505628
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 4118814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0004-2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIATA ACTIVE; RIATA ACTIVE
• Outcome Attributed to Adverse Event: Required Intervention