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

Model Number CD3357-40Q

Device Problems Defective Alarm (1014); Premature Discharge of Battery (1057)

Patient Problem Discomfort (2330)

Event Date 08/24/2019

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.Maude report number mw5089784 was received.

Event Description

Related manufacturer reference number: 2938836-2019-15194; 2938836-2019-15196; 2938836-2019-15197.It was reported that the patient's crt-d system exhibited several failures.The patient reported that he went to the emergency room after being in atrial fibrillation and that the device did not bring his heart rate down.It was also alleged that his merlin at home transmitter sent a transmission to the physician but did not trigger a patient notifier alert.The patient also alleged experiencing diaphragmatic stimulation that could not be resolved.It was suspected that the there was a possible malfunction of the leads that could have caused premature battery depletion.The patient has discomfort while laying down and feels a poking sensation.Further information about the event was requested but was unavailable.

Event Description

New information received notes that during a follow up in clinic, the patient was concerned that his implantable cardioverter defibrillator was on the advisory for premature battery depletion, although there was no elective replacement indicator (eri) alert or allegation of premature battery depletion.There was no reproducible diaphragm stimulation.The left ventricular outputs were left as originally programmed.The patient was stable.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9205793
• MDR Text Key: 162798343
• Report Number: 2938836-2019-15158
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508216
• UDI-Public: 05414734508216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000054439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82