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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-IPP
Device Problems Collapse; Failure to Cycle; Mechanical Problem
Event Date 09/11/2019
Event Type  Injury  
Event Description

It was reported that the inflatable penile prosthesis (ipp) reservoir was explanted due to a malfunction. "the pump stayed dimpled when inflating. Once pump was disconnected from reservoir it worked well. It was believed that there was a starve from the reservoir to the pump. The reservoir had 90cc of fluid left so there either was a kink or a fold that did not allow the fluid to be properly transferred. " the reservoir was explanted and a new reservoir was implanted in a different location in order to avoid the problem from happening again. Additional information received states the device issues began a few months prior to the revision surgery. The patient was doing "great" following surgery. Product was explanted but not expected to be returned. Should additional information be received or product be returned, a supplemental report will be filed upon completion of product analysis.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS
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 w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key9130880
Report Number2183959-2019-66421
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 09/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/27/2019 Patient Sequence Number: 1
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