BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2052669 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02680
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 1, 2010
    Report Date
    March 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT DEVELOPED EROSION OVER THE STIMLOC SITE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS LATER REPORTED THAT THE PT EXPERIENCED WOUND DEHISCENCE AND SCALP SORENESS/TENDERNESS. THE SKIN WAS THINNING OVER THE DEVICE. THERE WAS RIGHT FRONTAL AND PARTIAL SCALP SEPARATION, AN OPENING OVER THE DBS CAP. THE PT UNDERWENT SURGICAL INTERVENTION AND EXPLORATION OF THE RIGHT FRONTAL DEVICE. THE RIGHT SKIN FLAP WAS REVISED ALONG WITH REPLACEMENT OF THE NAVIGUS CLIP AND CAP. IV ANTIBIOTICS WERE ADMINISTERED. THE PT OUTCOME WAS GOOD AND NOTED AS NO INJURY. THE PT WAS TO RETURN IN THE SPRING TO DISCUSS FUTURE IMPLANT OF THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention PROGRAMMER: MODEL 7436, LOT# NFU020868P| LEAD: MODEL 3389S-40, LOT# V057193| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7428,| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V057193| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU022743V| EXTENSION: MODEL 7482A51, LOT# NHU178545V| IMPLANTED:| LOT# NFD109498H| EXTENSION: MODEL 7482A51, LOT# NHU178544V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU090903V| EXPLANTED:| LEAD: MODEL 3389, LOT# J0540935V| EXPLANTED: