BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3841021 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09911
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN OVERDISCHARGE OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS SUSPECTED. IT WAS FURTHER REPORTED THE INS WAS UNABLE TO BE READ BY A PHYSICIAN OR PATIENT PROGRAMMER. IT WAS STATED THE PATIENT HAD ATTEMPTED TO RECHARGE THE WEEK PRIOR TO REPORT AND HAD STIMULATION TWO WEEKS PRIOR TO REPORT. ADDITIONAL INFORMATION STATED THE PATIENT REMAINED IN OVERDISCHARGE WITH NO TELEMETRY AS OF A WEEK AFTER INITIAL REPORT. IT WAS REPORTED THAT ONE PHYSICIAN MODE RECHARGE (PMR) HAD BEEN PERFORMED AT THE TIME OF INITIAL REPORT WITH NO RESOLVE OF THE SITUATION. IT WAS FURTHER REPORTED THAT THREE MORE PMRS HAD BEEN PERFORMED SINCE WITH NO RESOLVE. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS ¿NOT RECEIVING THERAPY¿ AND WAS ¿FEELING THE SYMPTOMS AGAIN.¿ IT WAS STATED THE PATIENT¿S PHYSICIAN HAD ¿ORDERED A REPLACEMENT.¿ IT WAS NOTED THAT A DATE HAD NOT BEEN DETERMINED AS OF 13 DAYS AFTER INITIAL REPORT. ADDITIONAL INFORMATION STATED THE PATIENT EXPERIENCED PAIN AND A LOSS OF PARESTHESIA. IT WAS REPORTED THE PATIENT HAD ATTEMPTED TO RECHARGE THE INS BUT REPORTED THE RECHARGER COULD NOT SYNC WITH THE INS. IT WAS NOTED THE INS HAD OVERDISCHARGED AND PMRS HAD BEEN UNSUCCESSFULLY ATTEMPTED FOUR TIMES. IT WAS ADDITIONALLY NOTED THE PATIENT¿S PHYSICIAN REJECTED TO POSSIBILITY OF INS ROTATION. IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT¿S INS WAS EXPLANTED AND REPLACED. IT WAS NOTED THE PATIENT EXPERIENCED ¿PAIN RELIEF AGAIN¿ AT THAT TIME. IT WAS STATED THE PATIENT WAS ¿RECEIVING THE THERAPY CORRECTLY AND WAS GETTING BETTER AGAIN¿ FOLLOWING THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318685 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 Required Intervention