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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 72404257
Device Problems Mechanical Problem; Free or Unrestricted Flow
Event Date 01/01/2019
Event Type  Malfunction  
Manufacturer Narrative

Model: 72404155, lot: 1000025807, reservoir 65 ml pc/iz.

 
Event Description

It was reported that patient liaison spoke with patient with inflatable penile prosthesis (ipp) device. He states that for the first year his device worked perfectly and he was happy with the result. Patient states that now during intercourse he is losing the erection and has to repump during sex. He says physician feels like there is an issue with his pump. Patient liaison did go over troubleshooting maneuvers with him (to include burping, anti stiction and reboot) to see if it offers him any relief.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key9447661
Report Number2183959-2019-67984
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 12/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/11/2019
Device MODEL Number72404257
Device Catalogue Number72404257
Device LOT Number1000021375
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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