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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404235
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Erosion (1750)
Date of Event 01/16/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to erosion.The previous ipp components were explanted prior to the replacement surgery.The patient was implanted with a replacement pump, as well as left and right cylinders.A replacement reservoir was not implanted.The explanted ipp components are not expected to be returned.Should additional information be received, or product be returned, a supplemental report will be filed upon completion of the product analysis.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8259478
Report Number2183959-2019-60241
Device Sequence Number2035809
Product Code FHW
UDI-Device Identifier00878953003481
UDI-Public00878953003481
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/17/2019
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 Date06/11/2020
Device Model Number72404235
Device Catalogue Number72404235
Device Lot Number1000118842
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/16/2019
Initial Report FDA Received Date01/17/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age72 YR
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