BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3104839 · Received May 10, 2013

    Report

    Report Number
    3004209178-2013-07495
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377775 LOT# V017374, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 377775 LOT# V012668, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS "IN OFFICE ABOUT A MONTH AGO" WITH A SHOCKING SENSATION AND IT WAS NOTED ALL IMPEDANCES WERE NORMAL. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN TURNED OFF SINCE EASTER. IT WAS REPORTED, THE PATIENT HAD A MUSCLE TWITCH IN HER POSTERIOR LOW BACK, "RIGHT SIDE OF HER HIP GOING DOWN THE LEG." IT WAS NOTED, THE PATIENT WAS PROGRAMMED ON ONE LEAD (CONTACT 12+, CONTACT 14-, AND CONTACT 15+). IT WAS NOTED, THE PATIENT'S INS AS IMPLANTED ON HER RIGHT SIDE ABDOMEN AND THE LEAD WAS THORACIC. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER REPORTED THE PATIENT WAS BEING REFERRED TO A DIFFERENT PHYSICIAN FOR FURTHER X-RAYS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS WAITING ON WORKMAN¿S COMPENSATION TO APPROVE EVERYTHING. IT WAS NOTED ¿JUST A REFERRAL HAD BEEN SENT TO THE PHYSICIAN¿S OFFICE FOR FURTHER EVALUATION.¿ A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EVERY TIME THE PATIENT MOVED ¿IN THE SEAT¿, IT WOULD SURGE THAN ¿JUST BE GONE.¿ IT WAS NOTED THAT THE PATIENT HAD CRAMPS FROM THE SHOCKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT ¿HAD ORDERS FOR AN X-RAY AND THEN A FOLLOW-UP.¿ IT WAS FURTHER STATED THE PATIENT WAS ¿STILL WAITING ON A REPLACEMENT DATE AND APPROVAL FROM WORKMAN COMPENSATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206601 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR