BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR MRI

    MDR report key: 4152865 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18542
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 15, 2014
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97792, LOT# N433621, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNKNOWN IF THERE WAS A 50% OR GREATER REDUCTION IN SYMPTOMS. THE PATIENT REPORTED HAVING MULTIPLE SEIZURES THAT HER MEDICATION WAS NOT CONTROLLING. SHE COMPLAINED OF VNS NOT SPINAL CORD STIMULATOR (SCS) PROBLEMS OTHER THAN DEPLETION. THE PATIENT CALLED THE MANUFACTURER REPRESENTATIVE (REP) BECAUSE SHE THOUGHT HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. THE REP MET WITH THE PATIENT ON (B)(6) 2014 AND THE PATIENTS SCS WAS DEPLETED, NOT OVERDISCHARGED. THE REP HAD THE PATIENT RECHARGE UNTIL IT WAS ABOUT 25% FULL. THE REP CHECKED THE PROGRAMMING AND IMPEDANCES. THE PROGRAMS WERE NOT CHANGED. THE PATIENT REPORTED APPROPRIATE COVERAGE. THE PATIENT DID NOT EXPERIENCE A LOSS OF THERAPEUTIC EFFECT OR STIMULATION. IT WAS NOTED THE PATIENT DID NOT REPORT ANYTHING REGARDING THE PROBLEMS WITH THE SCS INCREASING OR DECREASING WHEN IT WASN'T SUPPOSED TO. THE PATIENT TURNED OFF HER ADAPTIVE STIMULATION SHORTLY AFTER IT WAS ENABLED AFTER HER IMPLANT. NO REPROGRAMMING WAS NECESSARY AND ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE ISSUE WAS REPORTEDLY NOT DEVICE RELATED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN HER WHEELCHAIR WHEN SHE BACKED UP AND HIT HER DRESSER AND HER STIMULATION CAME ON WHEN IT WAS NOT SUPPOSED TO. ADAPTIVE STIMULATION WAS TURNED OFF AT THE TIME OF THIS REPORT. THERE WERE TWO TIMES WHEN SHE STOOD UP, STIMULATION INCREASED AND CAUSED HER LEFT KNEE TO GO OUT. THIS HAPPENED MOST RECENTLY ABOUT A MONTH AGO. AFTER IT HAPPENED, SHE TURNED STIM OFF. THE PATIENT COULDN¿T GET THE IMPLANTABLE NEUROSTIMULATOR (INS) TO CHARGE, SO SHE CALLED AND MET WITH THE MANUFACTURER REPRESENTATIVE (REP). THE PATIENT¿S ISSUE WAS SHE WAS NOT PUTTING THE INSR ANTENNA IN THE CORRECT SPOT. THE INS DID NOT NEED TO BE ¿JUMP STARTED.¿ THIS WAS REPORTEDLY EARLIER IN THE MONTH. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REPORTEDLY HAD A LOT OF SEIZURES AND THEY AFFECT HER SHORT TERM MEMORY. THE PATIENT REPORTEDLY "HAS GRAND MAL SEIZURES" AND HAS THROWN HER RIGHT SHOULDER OUT TWICE. OF NOTE: INFORMATION THAT WAS PREVIOUSLY REPORTED HAS BEEN OMITTED FROM THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630922 RESTORE SENSOR MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other