BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2760543 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08539
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-9, LOT# N324369, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE PUMP FOUND NO PUMP ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A VOLUME DISCREPANCY WITH THE PUMP. THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV). REPORTER WAS UNABLE TO PROVIDE SPECIFIC VALUES FOR VOLUMES; HOWEVER, THE ARV AND ERV DIFFERENCE WAS GREATER THAN 25%, THE VOLUME DISCREPANCY HAD BEEN ENCOUNTERED WITH EACH OF THREE REFILLS SINCE THE (B)(6) PUMP IMPLANT. THE PATIENT FELT THE PUMP WAS WORKING "ONLY WHEN HE BOLUSES HIMSELF" WITH THE PERSONAL THERAPY MANAGER (PTM). NO SPECIFIC SYMPTOMS WERE REPORTED. TROUBLESHOOTING WAS BEING CONSIDERED. THE MEDICATION IN THE PUMP WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD A LACK OF EFFECT AND INCREASED PAIN. ON (B)(6) 2012, A DYE STUDY WAS ATTEMPTED, BUT THE CATHETER WAS NOT ABLE TO BE ASPIRATED. THE PUMP WAS REPLACED AND THE PATIENT WAS "DOING WELL" AND HAD EXCELLENT PAIN CONTROL. AT THE TIME OF EXPLANT, THE EXPECTED RESIDUAL VOLUME WAS 24 ML AND THE ACTUAL RESIDUAL VOLUME WAS 36 ML. IT WAS NOTED THAT DURING SURGERY THE CATHETER WORKED "FINE."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT OUTCOME WAS "NO INJURY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention