BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2003730 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01426
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    April 1, 2010
    Report Date
    February 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PT HAD HER DEVICE EXPLANTED IN (B)(6) 2010. PT STATED SHE HAD "ISSUES" AND HCP DID A CT MYELOGRAM AND FOUND ONE OF THE LEADS WAS COMPRESSED AGAINST HER SPINAL CORD. THERE WAS A GROWTH BETWEEN THE LEAD AND THE SPINAL CORD SO THE HCP EXPLANTED THE DEVICE. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D A F/U REPORT WILL BE SENT.

    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 47 YR Female Required Intervention ACCESSORY: MODEL 37752, LOT# NKA110022N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB024229V| EXTENSION: MODEL 37081, LOT# NJB024230V| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N148885003| PROGRAMMER: MODEL 37743, LOT# NKE105165N| EXTENSION: MODEL 37081, LOT# NJB024229V| ACCESSORY: MODEL 37752, LOT# NKA110022N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N148885003| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE105165N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB024230V| EXPLANTED: