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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 720185-01
Device Problems Failure to Cycle (1142); Mechanical Problem (1384); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to the device not working and the pump stayed flat with an inflatable penile prosthesis (ipp).After several attempts to get the pump to work the physician decided to replace the reservoir and following connecting the device the device cycled properly.
 
Event Description
It was reported that the patient underwent a revision procedure due to the device not working ad the pump stayed flat with an inflatable penile prosthesis (ipp).After several attempts to get the pump to work the physician decided to replace the reservoir and following connecting the device the device cycled properly.The physician also identified kinked tubing.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10697297
MDR Text Key211888061
Report Number2183959-2020-04812
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953005669
UDI-Public00878953005669
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/08/2021
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? Yes
Device Operator Lay User/Patient
Device Expiration Date11/24/2021
Device Model Number720185-01
Device Catalogue Number720185-01
Device Lot Number1000358589
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2020
Initial Date FDA Received10/19/2020
Supplement Dates Manufacturer Received01/07/2021
Supplement Dates FDA Received01/08/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age48 YR
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