BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1812624 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-06179
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S NEUROSTIMULATOR DEVICE WAS EXPLANTED AND REPLACED. UPON REMOVING THE LEAD, IT WAS NOTED THAT PART OF THE SHEATH/SILICONE COATING MIGHT HAVE REMAINED INSIDE THE PATIENT, AS THE VERY TAIL END OF THE LEAD APPEARED FRAYED, OR AS FOUR LITTLE HAIR SIZED FIBERS. THE LEAD HAD BEEN CUT AT THE CERVICAL AREA, AND ABOUT 4 INCHES OF THE LEAD WAS REMOVED. THEY THEN TRIED TO PULL THE REST OF THE LEAD FROM THE LOCATION OF THE DEVICE POCKET. THE LEAD HAD BEEN DISPOSED OF. THE PATIENT'S OUTCOME WAS NOT REPORTED, NOR WAS THE REASON FOR THE EXPLANT/REPLACEMENT OF THE DEVICES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE120594N| IMPLANTED:| MODEL UNKNOWN, LOT# B0767864| EXPLANTED:| LEAD: MODEL 3890, LOT# B0720906K| LEAD: MODEL 39565-65, LOT# N222290003| IMPLANTED: