BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3001305 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03621
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377745 LOT# V002679, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID: 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT I: 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE INS "DIDN'T WORK." IN THE BEGINNING THE PATIENT WOULD HAVE TO TURN INS UP SO HIGH TO COVER THE AREA THEY NEEDED TO THAT IT WOULD CAUSE PAIN. THE PATIENT WAS REPROGRAMMED "MANY TIMES." THE ONLY WAY THE PATIENT BELIEVED IT WOULD WORK WAS IF THEY PUT A NEW LEAD IN , HIGHER UP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT "STILL HAD CONCERNS WITH HER DEVICE OR THERAPY" AND THAT THEY HAD "NOT SOUGHT FURTHER HELP." FURTHER INFORMATION STATED "THE STIMULATION DID NOT AUTOMATICALLY TARGET THE PAIN." IT WAS ALSO STATED THAT IT WAS "UNKNOWN" WHETHER THE EVENT WAS DUE TO THE IMPLANTABLE NEUROSTIMULATOR. IT WAS ALSO NOTED THAT THE "LEADS WERE NOT IN THE RIGHT POSITION FOR FUNCTION." THE PATIENT'S PHYSICIAN REPORTED, THE PATIENT "WANTED IT EXPLANTED" BUT SURGICAL INTERVENTION WAS "NOT YET" PLANNED. IT WAS ALSO NOTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BATTERY WAS DEAD. IN ORDER TO HIT THE RIGHT SPOTS THE PATIENT TURNED THE INS UP SO HIGH THAT IT SHOT DOWN ALL THE WAY TO THE FRONT OF THEIR BREASTS AND THEN IT FELT LIKE THEY WERE GETTING SHOCKED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS ALSO NOTED THAT WHEN SHE WOULD TURN IT UP HIGH SHE FELT LIKE IT WAS ELECTROCUTING HER IN HER BREASTS. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED 2015-(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104950 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention