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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3211-36
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/29/2018
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
During follow-up, the device was interrogated and the estimated longevity was less than expected.The physician alleged premature battery depletion.No intervention was performed and the physician will continue to monitor the patient.The patient was in stable condition.
 
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Brand Name
PROMOTE PLUS 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 Key8162432
Report Number2017865-2018-18833
Device Sequence Number14046111
Product Code NIK
UDI-Device Identifier05414734503693
UDI-Public05414734503693
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2016
Device Model NumberCD3211-36
Device Lot NumberS000004454
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/29/2018
Initial Report FDA Received Date12/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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