BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 8081583 · Received November 16, 2018

    Report

    Report Number
    2183959-2018-00128
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    November 2, 2018
    Report Date
    September 15, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MINNETONKA
    Product Code
    FHW
    UDI-DI
    00878953003610
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER: 72404253, SERIAL NUMBER: (NULL), LOT NUMBER: 103752005, MODEL DESCRIPTION: LGX PRECONNECT MS 21CM PS, IZ, IMPLANT DATE: (B)(6) 2015, EXPLANT DATE: (B)(6) 2018, EXPIRATION DATE: 09/22/2017, MANUFACTURE DATE: 10/08/2015, (B)(4). MODEL NUMBER: 72404134, SERIAL NUMBER: (NULL), LOT NUMBER: 923910008, MODEL DESCRIPTION: BELT CUFF FGS, 6.0 CM, IZ, IMPLANT DATE: (B)(6) 2015. EXPLANT DATE: (B)(6) 2018, EXPIRATION DATE: 02/24/2016, MANUFACTURE DATE: 03/10/2015, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS PUMP COMPONENT COLLAPSED AND WOULD NOT ACTIVATE AFTER USING THE DEFLATE BUTTON. THE PATIENT SAW THEIR PHYSICIAN AND REPORTED THE COLLAPSED PUMP AND THAT THE PROBLEM HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST FEW WEEKS. THE PATIENT TRIED TO RE-CYCLE THE PUMP USING THE DEFLATE BUTTON AND HAD SOME SUCCESS BUT AGAIN EXPERIENCED ISSUES ACTIVATING. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS SUBSEQUENTLY REPORTED THE IMPLANT WAS REMOVED AN REPLACED DUE TO PUMP FAILURE AND STICKY PUMP. THIS COMPLAINT WAS INITIALLY SUBMITTED TO FDA VIA ASR REPORT Q3 2016 AND ADDITIONAL INFORMATION WAS RECEIVED BY BOSTON SCIENTIFIC. DUE TO THE REMOVAL OF EXEMPTION E1997037, THIS INFORMATION IS PROVIDED VIA SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917851 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC - MINNETONKA 72404253 00878953003610

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R