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

Model Number	CD3265-40
Medical Device Problem Codes	Failure to Interrogate (1332); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2020
Type of Reportable Event	Serious Injury
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.The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.
Event or Problem Description
It was reported that the asymptomatic patient presented remotely.It was seen that the device received a battery performance alert.No procedure has taken place or been scheduled at this time.The patient was reported stable with no patient consequences.
Event or Problem Description
New information received indicated that the device was explanted and replaced on (b)(6)2020.It was also noted that the device was in backup vvi mode and had loss of telemetry.
Event or Problem Description
New information received indicated that the patient was doing well during and post procedure.
Additional Manufacturer Narrative
Premature battery depletion was confirmed by analysis.No sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.

• Brand Name: QUADRA ASSURA (DDQP+)
• 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: 10040405
• Report Number: 2017865-2020-05869
• Device Sequence Number: 16923177
• Product Code: NIK
• UDI-Device Identifier: 05414734505666
• UDI-Public: 05414734505666
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/20/2020

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: 02/28/2015
• Device Model Number: CD3265-40
• Device Catalogue Number: CD3265-40
• Device Lot Number: 4223351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/15/2020; 07/01/2020; 08/13/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 07/01/2020; 07/21/2020; 08/20/2020
• 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; Z-0117-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR