MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40Q

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Pacing Problem (1439)

Patient Problems Fainting (1847); No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient presented in the emergency room with symptoms of pre-syncope that did not have pacing support.Physician was unable to communicate with the device.When the device was interrogated two days before, device longevity was 2.5 years.Interrogating in another room with another programmer did not resolve the issue.Pre-mature battery depletion was suspected.Deice was explanted and replaced without issues.The patient was stable before, during, and after the procedure and will continue to be monitored going forward.The patient was no longer symptomatic following the procedure.

Manufacturer Narrative

No conclusion code available; the reported field event of an inability to interrogate the device was confirmed in the laboratory and was due to premature battery voltage.Based on all available parameter and usage information, device longevity was found to be below expected limits.Review of the device image also confirmed no pacing during backup vvi mode.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 QUADRA CRT-D, US MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6097478
• MDR Text Key: 59718423
• Report Number: 2938836-2016-14101
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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: 06/06/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: CD3249-40Q
• Device Lot Number: 3889087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/13/2016; 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• 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