BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3071516 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06686
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8576, LOT# N121183, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8832, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PUMP REVISION SURGERY, THE PHYSICIAN OBTAINED RESULTS OF A MAGNETIC RESONANCE IMAGING (MRI) SCAN WHICH REVEALED SUSPECTED FINDINGS OF AN INFECTION. THE PATIENT WAS REFERRED TO INFECTIOUS DISEASES (ID) FOR AN EVALUATION. A BONE BIOPSY WAS REQUESTED BY ID PRIOR TO THE PUMP SURGERY. THE RESULTS OF THE BIOPSY WERE INITIALLY REPORTED AS PENDING. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS REPORTED AS ALIVE WITH NO INJURY AND NO DRUG WAS IN THE PUMP. IN ADDITION, REPORTEDLY THE PATIENT RECEIVED A 'POTENTIALLY CONTAMINATED' LUMBAR EPIDURAL STEROID INJECTION (LESI). IT WAS LATER REPORTED THAT THE BIOPSY HAD BEEN ORDERED BUT NOT YET COMPLETED. 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
    172786 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other