BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2342595 · Received November 18, 2011

    Report

    Report Number
    3004209178-2011-09280
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 25, 2011
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 377860, LOT# V011576, IMPLANTED: 2006-(B)(6), EXPLANTED: UNKNOWN, PROGRAMMER MODEL 37742, SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ZINGING SENSATION AND THE DEVICE TURNED OFF AND ON AGAIN. IT WAS ALSO MENTIONED THAT A NUMBER OF YEARS AGO THE PATIENT ENDED UP ON THE FLOOR UNABLE TO MOVE AFTER TAKING SOME MEDICATION. THE PATIENT STOPPED TAKING THE MEDICATION AND RECOVERED. THE NAME OF THE MEDICATION WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY WOULD GET ¿ZINGS¿ IF THEY DIDN¿T KEEP THEIR BACK STRAIGHT. THE PATIENT WAS IMPLANTED FOR NON-MALIGNANT PAIN.

    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 63 YR