BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8578045 · Received May 3, 2019

    Report

    Report Number
    2183959-2019-62833
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 3, 2019
    Report Date
    July 29, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002712
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: 72404310, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 839632005, GTIN: (B)(4), DESCRIPTION PUMP MS, EXPIRATION DATE: 07/24/2018, MANUFACTURER DATE 08/26/2013. MODEL NUMBER/CATALOG NUMBER: 72404161, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 861191018, GTIN: (B)(4), MODEL/CATALOG DESCRIPTION RESERVOIR 65ML PC, EXPIRATION DATE: 12/06/2018, MANUFACTURER DATE: 12/23/2013. DEVICE EVALUATION: THE PUMP WAS RETURNED AND ANALYZED. THE CUFF AND BALLOON REMAIN IMPLANTED. THE REPORTED ALLEGATION OF FLUID LOSS WAS NOT CONFIRMED VIA PRODUCT ANALYSIS OF THE PUMP, HOWEVER, THE DEFLATION TEST RESULTS WERE OUT OF SPECIFICATION, NO ESCALATION TO NCEP, CAPA, OR SCAR IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS PUMP COMPONENT REMOVED DUE TO TUBING CRACK OF LEFT CYLINDER. THE OLD RESERVOIR WAS NOT REMOVED. . A NEW INFLATABLE PENILE PROSTHESIS PUMP AND RESERVOIR WERE IMPLANTED. THE EVENT WAS RESOLVED FOLLOWING THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT SINCE THE CRACK ON TUBING WAS CLOSE TO PUMP AND RESERVOIR, IT WAS NOT RELATED WITH CYLINDER; THEREFORE THE CYLINDER WAS NOT REPLACED. THERE WAS A FLUID LOSS. THE PATIENT EXPERIENCED SYMPTOMS 2 WEEKS AHEAD OF THE SURGERY. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT GOT WELL.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE: MODEL NUMBER/CATALOG NUMBER 72404310, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 839632005, GTIN (B)(4), DESCRIPTION PUMP MS, EXPIRATION DATE 07/24/2018, DEVICE MANUFACTURER DATE 08/26/2013. MODEL NUMBER/CATALOG NUMBER 72404161, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 861191018, GTIN (B)(4), MODEL/CATALOG DESCRIPTION RESERVOIR 65ML PC, EXPIRATION DATE 12/06/2018, DEVICE MANUFACTURER DATE 12/23/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS PUMP COMPONENT REMOVED DUE TO TUBING CRACK OF LEFT CYLINDER. THE OLD RESERVOIR WAS NOT REMOVED. . A NEW INFLATABLE PENILE PROSTHESIS PUMP AND RESERVOIR WERE IMPLANTED. THE EVENT WAS RESOLVED FOLLOWING THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT SINCE THE CRACK ON TUBING WAS CLOSE TO PUMP AND RESERVOIR, IT WAS NOT RELATED WITH CYLINDER; THEREFORE THE CYLINDER WAS NOT REPLACED. THERE WAS A FLUID LOSS. THE PATIENT EXPERIENCED SYMPTOMS 2 WEEKS AHEAD OF THE SURGERY. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT GOT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370721 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404014 869070003 00878953002712

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R