BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2991513 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03399
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 13, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-33 LOT# J0333606V, IMPLANTED: 2003 (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: 3708360 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 HAD HAD A STOMACH SURGERY AND SOMETHING INADVERTENTLY WAS DONE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BY PULLING AND TUGGING ON THE LEAD. IT WAS STATED THAT THE PATIENT WAS TOLD IT WAS NOT POSSIBLE TO FIX IT AND THE PATIENT WOULD HAVE TO HAVE IT EXPLANTED. HE HAD NOT BEEN ABLE TO EAT DUE TO STOMACH ISSUES. NINE DAYS LATER, IT WAS REPORTED THAT 3-4 WEEKS PRIOR PATIENT'S FEEDING TUBE WAS BEING SWITCHED AND "THEY HOOKED ON TO THE PATIENT'S INS WHICH WAS BELOW HIS RIB CAGE." IT WAS STATED, THE DEVICE WAS STICKING OUT OF HIM AND THAT THERE WERE HOLES WHERE THE LEADS WERE STICKING OUT AND BLEEDING. ONE WEEK LATER IT WAS REPORTED THAT INS REVISION HAD NOT BEEN PLANNED YET. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HURT TERRIBLY AND WAS VERY UNCOMFORTABLE. IT WAS FURTHER NOTED THAT THE DEVICE TORE "LOOSE FROM ITS INTERNAL RESTING SPOT."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INS WAS MALFUNCTIONING, AND HAD BEEN PULLED LOOSE. THE PATIENT HAD MET WITH A MANUFACTURER REPRESENTATIVE WHO HAD BEEN UNABLE TO READ THE INS. IT WAS NOTED THAT THE INS HAD BEEN OFF FOR SIX WEEKS, AND THE PATIENT WAS TOLD TO RECHARGE. THE PATIENT RECHARGED AND A NURSE TURNED THE INS BACK ON, HOWEVER ABOUT TEN MINUTES LATER THE PATIENT SNEEZED AND IT WAS STATED THAT THE PATIENT WAS ELECTROCUTED AND FELT LIKE HE HAD BEEN HIT IN THE HEAD WITH A BASEBALL BAT. THE PATIENT TURNED THE INS OFF, BUT EXPERIENCED A RETURN OF SYMPTOMS INCLUDING CARDIO-SPASMS. THE PATIENT STATED THAT HIS HEART AND STOMACH EXPERIENCED SEVERE SPASMS. THE PATIENT WANTED THE INS REMOVED OR FIXED, BUT WAS UNABLE TO FIND A DOCTOR. IT WAS ALSO REPORTED THAT FOLLOWING THE STOMACH SURGERY THE PATIENT HAD A FEEDING TUBE AND EQUIPMENT IMPLANT, BUT HE WAS ALLERGIC TO IT. IT WAS REMOVED, BUT THE PATIENT BELIEVED THAT HIS BODY THOUGHT THE INS WAS LATEX, AND WAS REJECTING IT. IT WAS NOTED THAT THERE WERE NO OPEN SORES OR EROSION YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96005 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1