BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2160847 · Received July 7, 2011

    Report

    Report Number
    3007566237-2011-05158
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN INFECTED BACK INCISION WITH REDNESS AND BLISTERING NOTED AT THE BACK INCISION SITE. THE PT WAS HOSPITALIZED. THE CATHETER (ISSUE UNK) WAS EXPLANTED AND THE PT RECEIVED ANTIBIOTIC THERAPY ON (B)(6) 2011. THE OUTCOME WAS REPORTED AS ONGOING EVENT. THE DRUG INFUSED VIA THE DEVICE WAS BACLOFEN (DOSE UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R CATHETER: MODEL 8709SC, LOT# N281307002| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# J0058149R| IMPLANTED: