BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1063239 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-03349
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    March 1, 2007
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: EXTENSIONS (2).

    Description of Event or Problem · 1

    THE PT FELT A PAINFUL 'HAIR-PULLING' FEELING ON HIS HEAD, NECK, AND SCALP 90% OF THE TIME AFTER THE LEADS WERE IMPLANTED. THE LEAD PULLED FROM THE SIDE OF HIS FACE DOWN TO THE NEUROSTIMULATOR IN THE CHEST. THE PULLING WAS VERY UNCOMFORTABLE, IRRITATING AND PAINFUL. THE HCP REPORTED THAT THE PT HAD PERSISTENT TIGHTNESS/PAIN IN THE LEFT NECK REGION NEAR THE EXTENSIONS. THE PT ALSO HAD HEADACHES. THE PT UNDERWENT REVISION OF THE EXISTING EXTENSIONS TO REDUCE THE PULLING FEELING (DATE NOT REPORTED). THE EXTENSIONS WERE REPLACED. THE PAIN AND DISCOMFORT PERSISTED. THE LEAD WAS WRAPPED UP IN THE TISSUE. THE DEVICE WORKED EXTREMELY WELL AND THE PT DID NOT WANT TO LOSE THERAPY. THE HCP REPORTED THE EVENT WAS A 'NON-SERIOUS INJURY/ILLNESS'.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention EXTENSION MODEL# 748251| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 7436 LOT# NFU014244P| LEAD MODEL# 3387S-40| IMPLANTED:| EXPLANTED:| EXTENSION MODEL# 748251| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD MODEL# 3387S-40| IMPLANTED: