BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3803243 · Received May 9, 2014

    Report

    Report Number
    3007566237-2014-01294
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PERSONAL THERAPY MANAGER (PTM) WAS NOT UPLOADING INFORMATION. THE REFILL DATE WAS NOT ACCURATE. THE DRUG BEING USED WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE SAW THE PATIENT ON 2014-(B)(6) FOR A DYE STUDY. THE CATHETER AND PUMP WERE REPORTEDLY BOTH WORKING PERFECTLY AS DETERMINED FROM THE STUDY. THE PATIENT REPORTEDLY WANTED TO KNOW IF THEY WOULD BE ABLE TO SET THE DATE AND TIME OF THE PTM. THE PTM HAD REPORTEDLY BEEN SET AFTER INTERROGATION WITH THE CLINICIAN PROGRAMMER. THERE WAS REPORTEDLY NOTHING WRONG WITH ANY OF THE EQUIPMENT SUCH AS THE PTM, CATHETER, OR PUMP. THE MANUFACTURER'S REPRESENTATIVE DID NOT HAVE THE PATIENT'S NAME IN ANY OF THEIR RECORDS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281485 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1