BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 9507373 · Received December 20, 2019

    Report

    Report Number
    3004209178-2019-24301
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER OF A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR BOTH BLADDER AND BOWEL. CALLER STATED THAT THE PATIENT HAS BEEN EXPERIENCING PAIN AND WANTED TO KNOW IF HE SHOULD INCREASE STIM. CALLER MENTIONED THAT PATIENT IS TAKING PAIN PILLS FOR THIS PAIN, BUT THE PT DOESN'T LIKE TO TAKE THE PILLS. PATIENT SERVICES TRIED TO CLARIFY IF THE PAIN WAS FROM THE STIM OR THE SURGERY, HE THINK THAT THE PAIN ISN'T RELATED TO THE STIM, BUT THE CALLER DID NOT KNOW. PATIENT SERVICES ADVISED NOT TO INCREASE STIM, IF STIM IS CAUSING THE PAIN. CALLER ALSO MENTIONED THAT PATIENT IS HESITANT TO MAKE CHANGES TO HER THERAPY BECAUSE SHE FEELS LIKE SHE MAY HAVE AN INFECTION OVER HER INCISION EVEN THOUGH SHE HAS NO SIGNS OF INFECTION (NO FEVER, REDNESS, OR SWELLING).THERE WERE NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296210 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other