BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT LOW IMPEDANCE

    MDR report key: 1013880 · Received March 14, 2008

    Report

    Report Number
    6000153-2008-01267
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED FEELING NUMBNESS IN THE HANDS, AND PAIN WHERE THE TIPS OF THE LEADS ARE LOCATED. THE SYMPTOMS BEGAN FOLLOWING IMPLANT. THE PT REMAINED AT HOME AND WAS AWARE OF STIMULATION ON/OFF OPTIONS UNTIL THE DEVICE COULD BE CHECKED BY THE HCP. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT. SEE MFR REPORT #60000153200801266.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT LOW IMPEDANCE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 3778 V036271034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| LOT# NJH717956H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 37711| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 37081 LOT# NJB026884V| EXPLANTED:| EXTENSION MODEL 37081 LOT#NJB026885V