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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA CRT-D; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION PUNCTUA CRT-D; IMPLANTABLE DEVICE Back to Search Results
Model Number N051
Medical Device Problem Codes Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/06/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Surgical intervention has been performed as this device was explanted.No additional adverse patient effects were reported.
 
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Brand Name
PUNCTUA CRT-D
Common Device Name
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8581485
Report Number2124215-2019-08483
Device Sequence Number16952904
Product Code LWP
UDI-Device Identifier00802526480928
UDI-Public00802526480928
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P010012/S255
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/06/2019
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 Lay User/Patient
Device Expiration Date09/28/2013
Device Model NumberN051
Device Catalogue NumberN051
Device Lot Number100456
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/07/2019
Initial Report FDA Received Date05/06/2019
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 Hospitalization; Life Threatening; Required Intervention;
Patient Age68 YR
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