BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2133550 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04447
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 18, 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
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT INITIALLY HAD GOOD RESPONSE TO HER IMPLANTABLE NEUROSTIMULATOR (INS) AND GOOD COVERAGE OF HER LEG PAIN. SHE GRADUALLY DEVELOPED A TREMOR AND EXPERIENCED A METALLIC TASTE IN HER MOUTH AS WELL AS A GENERAL FEELING OF BEING UNWELL. THE PT REQUESTED THAT HER ENTIRE SYSTEM BE EXPLANTED. THE SYSTEM WAS EXPLANTED AND NOT REPLACED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PT WAS NOT INJURED AND WAS DOING FINE. A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37714 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3877, LOT # 0204242501| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB083455V| IMPLANTED:| LEAD: MODEL 3877, LOT # 0204253490| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB083454V| IMPLANTED: