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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA ICD; PACEMAKER
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BOSTON SCIENTIFIC CORPORATION PUNCTUA ICD; PACEMAKER Back to Search Results
Model Number E053
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/31/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that this pacemaker system was explanted.No product allegations have been received at this time.A new system was successfully placed.No additional adverse patient effects were reported.
 
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Brand Name
PUNCTUA ICD
Common Device Name
PACEMAKER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12113773
Report Number2124215-2021-16224
Device Sequence Number14343933
Product Code LWP
UDI-Device Identifier00802526480706
UDI-Public00802526480706
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P960040/S235
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/03/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date11/02/2014
Device Model NumberE053
Device Catalogue NumberE053
Device Lot Number100796
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/17/2021
Initial Report FDA Received Date07/03/2021
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; Required Intervention;
Patient Age62 YR
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