BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1926201 · Received November 10, 2010

    Report

    Report Number
    3004209178-2010-09166
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4. FINAL ANALYSIS OF THE PROGRAMMER REVEALED THERE WAS A CRACK SOLDER JOINT ON THE ANTENNA JACK. ALL OF THE ANTENNA JACK PINS WERE RESOLDERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SITTING AT HOME WATCHING TV AND ALL OF A SUDDEN HER STIMULATION FELT LIKE IT WAS "RAMPING ON ITS OWN." THE PT GOT TO HER PT PROGRAMMER AND TRIED TO TURN THE STIMULATION OFF. THE PT WENT TO HER HCP FOR FOLLOW-UP, AND THE HCP STATED THE BATTERY WAS FUNCTIONING OKAY. THE STIMULATION COULD NOT BE ADJUSTED WITH THE ANTENNA ATTACHED TO THE PT PROGRAMMER WITHOUT SOME CONTINUED PRESSING OF BUTTONS. THE BATTERIES HAD BEEN REPLACED THE PREVIOUS DAY, AND THE PT PROGRAMMER DISPLAYED THE "CALL YOUR DOCTOR" ICON. THE DEVICE WAS TURNED DOWN AND EVENTUALLY OFF AT THE HCP'S OFFICE. WITHOUT STIMULATION, THE PT HAD A RETURN OF SYMPTOMS THAT WERE PAINFUL, AND THE PT WAS SENT TO THE EMERGENCY ROOM FOR HER PAIN. THE PT ALSO HAD SWELLING. THE PT HAD ORAL MEDICATION THAT "WAS NOT HELPING." THE PT HAD FALLEN A COUPLE OF WEEKS PRIOR TO THE INCIDENT, BUT THE PT DID NOT HURT ANYTHING WHEN SHE FELL. THE FOLLOWING DAY, THE STIMULATION STARTED INCREASING WHILE THE PT WAS NOT USING THE PT PROGRAMMER. THE PT RECEIVED A NEW PROGRAMMER AND SHE WAS ABLE TO USE THE PROGRAMMER TO BRING UP THE INS SETTINGS. THE PT HAD STIMULATION, AND SHE WAS NOT BEING SHOCKED. THE PT HAD AN APPOINTMENT TO GO TO THE DOCTOR ON "MONDAY." ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB058201V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V239741005| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE126740N