BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2832955 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10285
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 18, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION (DESCRIBED AS A 'SPIRIT') FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WHEN THE LAID DOWN ON THEIR BACK WHICH STARTED 3 DAYS AGO. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE INS WORKED WELL FOR ABOUT A WEEK BUT ONCE IT RAN OUT OF INITIAL CHARGE IT DID NOT WORK AS WELL. THE PHYSICIAN AND THE COMPANY REPRESENTATIVE THOUGHT THAT THE INS MIGHT BE IMPLANTED TOO DEEP AND WAS SLANTED TO ONE SIDE. THE PATIENT WAS UNABLE TO CHARGE THE INS (NO COUPLING BARS) AND WAS UNABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER COMPONENT AS IT SHOWED THAT THE INS NEEDED TO BE RECHARGED. THE STIMULATION WAS REPORTED AS ON BUT THE PATIENT FELT THAT THE INS MIGHT BE COMPLETELY 'DEAD.' IT WAS REPORTED THAT WHEN THE INS DEVICE WAS WORKING AS INTENDED IT PROVIDED GOOD PAIN RELIEF. 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 PATIENT WAS HAVING A DIFFICULT TIME CHARGING HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE INS WAS IMPLANTED CORRECTLY, SO THE ISSUE WAS THOUGHT TO BE DUE TO SCAR TISSUE. FURTHER INFORMATION HAS BEEN REQUESTED, BUT NONE WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR