BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4111154 · Received September 23, 2014

    Report

    Report Number
    6000032-2014-00214
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# J0236900V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN WORRYING ABOUT THEIR DEVICE FOR A LONG TIME. THE PATIENT WAS GOING TO THE BATHROOM MORE THAN EXPECTED. THE PATIENT HAD MET WITH A NEW UROLOGIST AND REPRESENTATIVE AND WAS REPORTEDLY TOLD THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WOULD NEED TO BE REPLACED SOON, BUT DID NOT GIVE A REASON WHY. IT WAS UNKNOWN WHEN THIS OCCURRED. IT WAS STATED THAT IT WAS WORKING FINE, SO THE PATIENT WAS ¿LEERY¿ OF THAT ANSWER THINKING ¿THEY DID NOT KNOW WHAT THEY WERE TALKING ABOUT¿ AND WANTED TO FIND A DIFFERENT DOCTOR. THE PATIENT¿S BATTERY HAD DEPLETED. THE BATTERY DEPLETION WAS NORMAL, BUT HAD NOT BEEN EXPLANTED. THE PATIENT EXPERIENCED RETENTION AND A URINARY TRACT INFECTION. THE PATIENT¿S SYMPTOMS WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592651 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention