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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD1215-36
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/07/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the implantable cardioverter defibrillator exhibited premature battery depletion.It was noted that the estimated longevity on (b)(6) 2017 was 1.9 years to elective replacement indicator (eri) and on (b)(6) 2018 the estimated longevity was less than 3 months to eri.Device replacement was discussed.The patient was not symptomatic due to the event.
 
Event or Problem Description
New information available on (b)(6) 2018 states that the device was explanted and replaced.The patient was stable before, during and post procedure.
 
Additional Manufacturer Narrative
Interrogation of the device revealed the device was at eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Based on this information, there was no evidence of premature depletion.
 
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Brand Name
CURRENT ACCEL VR, 36J
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key7610180
Report Number2017865-2018-08916
Device Sequence Number13719377
Product Code NVZ
UDI-Device Identifier05414734502634
UDI-Public05414734502634
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial,Followup,Followup,Followup
Report Date (Section B) 12/03/2018
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 Date02/28/2011
Device Model NumberCD1215-36
Device Lot Number3096100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/23/2018
Supplement Date Received by Manufacturer06/19/2018
06/19/2018
11/19/2018
Initial Report FDA Received Date06/18/2018
Supplement Report FDA Received Date06/27/2018
06/27/2018
12/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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