BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112395 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07655
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N226699, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR 3 WEEKS DUE TO A WOUND THAT GOT INFECTED. THE WOUND WAS CAUSED BY THE PATIENT SCRAPING THE BACK OF HIS LEG. DUE TO THE PATIENT'S SPINAL CORD INJURY HE DID NOT KNOW HE HAD INJURED HIMSELF. WHEN THE PATIENT SUSTAINED THE INJURY THE SPASTICITY IN HIS LEGS WAS 'CRAZY.' THE SPASMS IN THE PATIENT'S LEG 'TORE THE SURGERY' THAT WAS DONE AND THEY HAD TO REDO THE SURGERY WHICH PROLONGED THE HOSPITAL STAY TO 3 WEEKS. THE PATIENT INDICATED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT REPORTED THAT THE DOCTOR KNEW HE WAS HAVING PROBLEMS BECAUSE HE SAW HIM TWICE THE MONTH BEFORE TO HAVE THE PUMP ADJUSTED BECAUSE OF THE WOUND. THE PATIENT REPORTED THAT THE DOCTOR DID NOT WANT TO ADJUST HIS PUMP WHILE HE WAS IN THE HOSPITAL. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212364 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R