BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2656194 · Received July 16, 2012

    Report

    Report Number
    3004209178-2012-05647
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    June 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377745, LOT# V013107, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-29, LOT# N147468, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED COUPLING AND COMMUNICATION ISSUES. THE IMPLANTABLE NEUROSTIMULATOR (INS) COMMUNICATED WITH BOTH THE CLINICIAN AND PATIENT PROGRAMMER, BUT THE PATIENT RECHARGER COULD ONLY GET TWO COUPLING BARS. THIS WAS CONSIDERED A RECENT CHANGE IN COUPLING. THERE WERE NO FALLS OR TRAUMA RELATED TO THE EVENT. THE INS WAS SUPERFICIAL IN THE POCKET, EASY TO FIND, AND LOOSE IN THE POCKET. USING THE ANTENNA LOCATE FEATURE, 70/70 WAS ACHIEVED AND GOT AS HIGH AS 84. WHEN A RECHARGE SESSION WAS INITIATED, ONLY TWO COUPLING BARS WERE ACHIEVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROVIDER FLIPPED THE INS WITHIN THE POCKET AND EIGHT COUPLING BARS WERE ACHIEVED WITH NO PROBLEMS. PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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