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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 72404230
Medical Device Problem Codes Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/10/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that due to a malfunctioning pump causing the device to not inflate, the patient had his inflatable penile prosthesis (ipp) explanted.The patient's outcome following this procedure was good.
 
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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 Key10485300
Report Number2183959-2020-03912
Device Sequence Number16900998
Product Code FHW
UDI-Device Identifier00878953003436
UDI-Public00878953003436
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/02/2020
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 Date03/10/2016
Device Model Number72404230
Device Catalogue Number72404230
Device Lot Number874002005
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/10/2020
Initial Report FDA Received Date09/02/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
861928009
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age62 YR
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