BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1930007 · Received November 18, 2010

    Report

    Report Number
    3004209178-2010-09751
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 1, 2010
    Report Date
    May 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE; IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATOR REACHED END-OF-LIFE/END-OF-SERVICE BEFORE THE ONE YEAR MARK. IF ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATES THE INFORMATION REPORTED IN MFG REPORT #3004209178201009159 REGARDING THE RIGHT SIDE DEVICE PERTAINS TO THIS EVENT. ANY ADDITIONAL INFORMATION PERTAINING TO THE RIGHT SIDE DEVICE WILL BE REPORTED IN THIS MDR. ADDITIONAL INFORMATION NOTED THAT THE PATIENT WAS UNABLE TO TURN STIMULATION BACK ON WITH PATIENT PROGRAMMER AFTER BEING TURNED OFF FOR AIRPORT AS PREVIOUSLY NOTED. IT WAS NOTED THAT THE PATIENT PROGRAMMER DISPLAYED A POOR COMMUNICATION SCREEN AT THAT TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT IT WAS UNKNOWN IF THE BATTERY DEPLETION WAS NORMAL OR PREMATURE. IT WAS NOTED THAT THE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS AN OUT-PATIENT PROCEDURE AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention LEAD: MODEL 3093, LOT# V304276| EXPLANTED:| LEAD: MODEL 3093, LOT# V304276| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD092570N| IMPLANTED: