BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1950078 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10292
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A STRONG PAIN AND "STRAIN" IN THE GLUTEUS AREA 40 MINS AFTER LEAVING AN ELECTRONICS STORE. IT WAS ALSO NOTED THAT THE PT HAD A DIFFERENT PARASTHESIA SENSATION WHICH LASTED UNTIL THE NEUROSTIMULATOR WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER THE NEXT DAY. SHE TRIED TO SWITCH THE DEVICE OFF WITH THE PT PROGRAMMER BUT AN ERROR MESSAGE "505" APPEARED ON THE SCREEN. WHEN THE DEVICE WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER, THE DEVICE WAS PROGRAMMED AT THE POWER-ON-RESET (POR) PARAMETERS. AFTER REPROGRAMMING TO THE PREVIOUS PROGRAM SETTINGS (0- 3+, 35 HZ, 210 MICROSECOND; 0.55 VOLTS) THE PT WAS REPORTED AS OKAY. NO PT INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1