BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3142119 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08513
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3550-P4 LOT# N329990N01, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD ¿TERRIBLE BACK PAIN¿ SINCE HER KNEE SURGERY. IT WAS NOTED THAT THE PATIENT COULD NOT STAND UP STRAIGHT AND WAS LEANING TO THE LEFT. IT WAS NOTED THAT THE PATIENT WAS TOLD THAT ¿HER SPINAL CORD WAS KIND OF POINTY AND THE THING KIND OF SLIDES TO THE LEFT.¿ IT WAS FURTHER NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244430 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