BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 6245425 · Received January 12, 2017

    Report

    Report Number
    3004209178-2017-00706
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Report Date
    February 14, 2017
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. CONCERNING THE SHOCKING SENSATION, THE PATIENT REPORTED THEIR HEALTHCARE PROVIDER CHECKED ALL WIRES TO MAKE SURE THEY WERE ALL IN CONTACT AND DID X-RAYS, WHICH WERE ALL FINE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYN. IT WAS REPORTED THAT THE PATIENT SOMETIMES WOULD GET A ¿ZAP¿ OR A ¿ZING¿ LIKE THEY WERE BEING ELECTROCUTED BRIEFLY. IT WAS STATED BY THE PATIENT THAT THIS SERVED AS AN INDICATOR TO LET THEM KNOW THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE CHARGED. THIS SHOCKING WOULD OCCUR INTERMITTENTLY. IT WAS REPORTED THAT THE SHOCKING HAD BEEN HAPPENING FOR YEARS, ¿A LONG TIME AGO.¿ THE PATIENT SLIPPED IN THEIR DRIVEWAY BUT CAUGHT THEMSELVES. THE PATIENT DID NOT THINK THAT THIS AFFECTED THE SYSTEM BECAUSE THE ZAP OR ZING SENSATIONS HAD BEGUN LONG BEFORE THEY SLIPPED ON THE DRIVEWAY. THE PATIENT STATED THAT THEY WOULD FOLLOW UP WITH A MANUFACTURER REPRESENTATIVE BEFORE THEIR HEALTH CARE PROFESSIONAL (HCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29417 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