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

Model Number CD3257-40

Device Problems Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/12/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2938836-2020-07618.It was reported that the patient presented in emergency room, inappropriate shocks due to backup vvi issue was observed.The device was explanted and replaced.The patient was stable.

Event Description

New information received notes that failure to interrogate was observed.

Manufacturer Narrative

Additional information: d10, h6.

Manufacturer Narrative

The reported field event of backup vvi (bvvi) was confirmed in the laboratory due to event queue overflow caused by an rf ic anomaly.The reported event of inappropriate shock and failure to interrogate could not be confirmed.The device was in backup mode upon receipt, so a full normal interrogation could not be performed.However, the device¿s telemetry was normal.The device was able to be interrogated via both inductive and rf telemetry during testing in the laboratory.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10320566
• MDR Text Key: 200239042
• Report Number: 2938836-2020-07617
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734505628
• UDI-Public: 05414734505628
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 4001556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL ST; TENDRIL ST
• Patient Outcome(s): Required Intervention
• Patient Weight: 47