Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA ICD; IMPLANTABLE DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION PUNCTUA ICD; IMPLANTABLE DEVICE Back to Search Results
Model Number E052
Medical Device Problem Code Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code Electric Shock (2554)
Date of Event 03/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As no further information is expected, our investigation is complete.This report will be updated should further information become available.
 
Event or Problem Description
It was reported that this device delivered a shock, in which the patient went into sinus tachycardia and five inappropriate shocks were delivered.Therapy was exhausted.This device remains in service.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PUNCTUA ICD
Common Device Name
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9965841
Report Number2124215-2020-07428
Device Sequence Number3636307
Product Code LWP
UDI-Device Identifier00802526480690
UDI-Public00802526480690
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P960040/S235
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/15/2020
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 Lay User/Patient
Device Expiration Date01/19/2016
Device Model NumberE052
Device Catalogue NumberE052
Device Lot Number100406
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/04/2020
Initial Report FDA Received Date04/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age44 YR
-
-