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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3231-40Q
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device is included in the battery performance alert advisory issued by abbott on (b)(6) 2017.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.
 
Event or Problem Description
Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.The patient condition was stable before, during, and after the procedure.
 
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Brand Name
UNIFY CRT-D
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9448737
Report Number2938836-2019-17143
Device Sequence Number480448
Product Code NIK
UDI-Device Identifier05414734504393
UDI-Public05414734504393
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 12/11/2019
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 Date10/31/2012
Device Model NumberCD3231-40Q
Device Catalogue NumberCD3231-40Q
Device Lot Number3380441
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/21/2019
Supplement Date Received by Manufacturer12/11/2019
Initial Report FDA Received Date12/10/2019
Supplement Report FDA Received Date12/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		Z-0004-2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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