BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2130255 · Received June 13, 2011

    Report

    Report Number
    3004209178-2011-04320
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    January 1, 2010
    Report Date
    May 16, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED COUPLING AND/OR COMMUNICATION ISSUES WITH HER IMPLANTABLE NEUROSTIMULATOR (INS). THE INS WAS NOT FLIPPED. SHE HAD A CEREBROSPINAL FLUID (CSF) LEAK IN HER INS POCKET AND HER INS WAS LOOSE IN THE POCKET. THE CSF FLOWERED THE TUNNELING PATH TO HER INS AND HER HEALTH CARE PROFESSIONAL REPAIRED THE LEAK. THE CSF DISSOLVED AND THE PT DID NOT HAVE ANY MORE ISSUES. A F/U REPORT WILL SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 79 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084024V| PROGRAMMER: MODEL 37743, LOT# NKE157108N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084023V| LEAD: MODEL 39565-50, LOT# N183687004| ACCESSORY: MODEL 37752, LOT# NKA146402N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: