BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 2161114 · Received June 17, 2011

    Report

    Report Number
    3004209178-2011-04559
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND INCISION SITE PAIN. SHE FELT BETTER AFTER HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF. A MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT AND REVIEWED BASIC INS USE. ABOUT A WEEK LATER, THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE SHE WAS IN A LOT OF PAIN. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE PSYCHIATRIC UNIT. ACCORDING TO THE PATIENT, THE HOSPITALIZATION WAS UNRELATED TO THE IMPLANTED SYSTEM. ABOUT A MONTH LATER, THE PATIENT EXPERIENCED ACUTE PAIN. SHE INCREASED HER INS TO THE HIGHEST VOLTAGE BUT WAS UNABLE TO FEEL STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR EXPLANTED:| LEAD: MODEL 3487A, LOT# V527691| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE167191N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V629841| EXTENSION: MODEL 37082, LOT# NKB009267V| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V437668001| IMPLANTED: