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 Premature Discharge of Battery (1057); Intermittent Capture (1080); Difficult to Interrogate (1331); Premature Elective Replacement Indicator (1483)

Patient Problems Dyspnea (1816); Fatigue (1849); No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device triggered early eri on merlin transmission.No therapies or programming changes were made at that time to explain the sudden drop in voltage.Patient was asymptomatic.Review of the transmission also revealed a significant latency between pacing output and ventricular depolarization, and intermittently also showed loss of capture.Patient was brought in for interrogation.The device was unable to interrogate due to the early battery depletion.Prior to the device replacement the patient had fatigue and dyspnea.The patient also had an av node ablation on (b)(6) 2016 and the next day the device was explanted and replaced.Patient is fine at home and will return for follow-up.

Manufacturer Narrative

The reported field event of an inability to communicate with the device was confirmed in the laboratory and was due to the battery voltage being less than the minimum voltage required for normal circuit operation.Based on all available parameter and usage information, device longevity was found to be below the expected limits.With an external power supply attached, the device functioned normally.No high current was detected during testing and the power consumption was normal.The original battery was returned to the vendor for further evaluation and analysis could not conclusively determine a root cause for the premature battery depletion.

Manufacturer Narrative

Premature battery depletion was confirmed by analysis.Bench testing on the device was performed, and no sources of high current were noted.In further analysis of the battery, lithium clusters were observed, but at the time of analysis the clusters did not appear to be in a location or size that would be sufficient to cause an internal short of the battery.As a result, the cause of the premature battery depletion could not be conclusively determined.However, from these analyses, in the absence of other root causes, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5989234
• MDR Text Key: 55986615
• Report Number: 2938836-2016-12063
• Device Sequence Number: 1
• Product Code: NIK
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: CD3357-40Q
• Device Lot Number: 4376966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0116-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR