BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 700 INFLATABLE PENILE PROSTHESIS

    MDR report key: 1913018 · Received November 19, 2010

    Report

    Report Number
    2183959-2010-00432
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING A REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT SENT. UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION. THE DEVICE STILL REMAINS IMPLANTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. IT HAS BEEN REQUESTED WE DO NOT CONTACT THIS PT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE WITH PEYRONIE'S DISEASE WAS IMPLANTED WITH AN IPP DEVICE ON (B)(6) 2009. ON (B)(6) 2010, THE PT REPORTED HIS IPP PUMP DOESN'T WORK, BUT HE IS HOLDING ONTO DEFLATE BAR WHILE TRYING TO SQUEEZE THE INFLATE BULB. THEN THE BULB COLLAPSES AFTER ONLY ONE SQUEEZE AND SLOWLY REFILLS. GAVE PT CORRECT METHOD. ON (B)(6) 2010, PT INDICATED HE NEEDED A REVISION SURGERY. ON (B)(6) 2010, PT SUGGESTED AGAIN HE WILL NEED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 700 INFLATABLE PENILE PROSTHESIS IPP JCW AMERICAN MEDICAL SYSTEMS, INC. 72404250 72404156

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability