BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3190437 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10900
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8835 LOT# SERIAL# (B)(4). PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE (B)(6) INFECTION INVOLVED A DIFFERENT PATIENT. THE INFECTION OCCURRED AT HIS IMPLANTABLE NEURO STIMULATOR (INS) SITE BECAUSE THE PATIENT REMOVED THE STAPLES HIMSELF AFTER IMPLANT SURGERY AND THEN TOOK A SHOWER. THE PATIENT¿S PUMP WAS REMOVED DUE TO THE MRSA INFECTION. THE PATIENT WAS NOT RE-IMPLANTED.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED IN MFG REPORT # 3004209178-2013-12742 THAT THE PATIENT HAD A (B)(6) INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE HOWEVER IT WAS LATER DETERMINED THAT THE MRSA INFECTION WAS RELATED TO THE PUMP SYSTEM. THE PATIENT EXPERIENCED AN MRSA INFECTION AT THE PUMP SITE WHICH WAS DUE TO HIM REMOVING THE STAPLES HIMSELF AFTER IMPLANT SURGERY AND THEN TAKING A SHOWER. THE PUMP WAS REMOVED DUE TO THE (B)(6). THE PATIENT WAS NOT RE-IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN MRSA INFECTION CAUSED BY PATIENT PICKING AT HIS INCISIONS AND PATIENT NOT SHOWING UP FOR FOLLOW-UP SECONDARY TO REMOVING HIS OWN STAPLES. THE PUMP WAS USED TO DELIVER HYDROMORPHONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289852 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R