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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 72404261
Medical Device Problem Codes Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/14/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient said he could not inflate or deflate his inflatable penile prosthesis (ipp) device.Once in surgery the pump was accessed and the device functioned normally.It was able to inflate and deflate with no issues.The pump and cylinders were removed and replaced with 11mm tactra.
 
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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 Key11096054
Report Number2183959-2020-06174
Device Sequence Number19735048
Product Code FHW
UDI-Device Identifier00878953003696
UDI-Public00878953003696
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/30/2020
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 Date12/17/2015
Device Model Number72404261
Device Catalogue Number72404261
Device Lot Number861881004
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/14/2020
Initial Report FDA Received Date12/30/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
72403872/886860010
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age78 YR
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