BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2567107 · Received May 9, 2012

    Report

    Report Number
    3004209178-2012-03148
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Report Date
    April 16, 2012
    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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 377775, LOT# V008916, IMPLANTED: (B)(6) 2006, EXPLANTED: NA. LEAD MODEL 377775, LOT# V012668, IMPLANTED: (B)(6) 2006, EXPLANTED: NA RECHARGER MODEL 37752, SERIAL# (B)(4). PROGRAMMER MODEL 37742, SERIAL# (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD COUPLING ISSUES BETWEEN THEIR EXTERNAL RECHARGER AND THE IMPLANTABLE NEUROSTIMULATOR (INS). SHE STATED THAT STARTED TO SEE LOW COUPLING (2 BARS) ABOUT 2 WEEKS AGO. IT WAS NOTED THAT SHE COULD COMMUNICATE WITH THE INS USING HER PROGRAMMER. THE PATIENT WAS ABLE TO PALPATE THE INS AND IT DID NOT FEEL LOOSE IN THE POCKET ALTHOUGH IT WAS REPORTED THAT IT FELT LIKE IT HAD MOVED FROM THE FRONT OF HER BODY TO HER RIGHT SIDE. SHE ALSO HAD GAINED (B)(6) RECENTLY. THE PATIENT HAD AN UPCOMING APPOINTMENT WITH HER PHYSICIAN IN (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HAD FLIPPED WHICH WAS WHY UNABLE TO INTERROGATE/PROGRAM DEVICE AND PATIENT'S PAIN INCREASED. AN X-RAY WAS TAKEN ON (B)(6) 2012 AND INDICATED DEVICE WAS ON ITS SIDE AND COULD NOT INTERROGATE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT WAS AWAITING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1