BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2925215 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00824
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN MRI OF THE LUMBAR REGION SCHEDULED FOR (B)(6) 2012 TO CHECK FOR GRANULOMA. THE PATIENT WAS EXPERIENCING PROBLEMS URINATING, BUT NOT TO THE POINT WHERE HE HAD TO CATHETERIZE HIMSELF. IT WAS UNCLEAR IF THE PATIENT WAS ALSO EXPERIENCING PAIN. THE SYMPTOMS HAD BEEN OCCURRING FOR ABOUT ONE WEEK. IT WAS NOTED THE PATIENT ALSO HAD CHRONIC KIDNEY STONES AND GALLSTONES AS WELL. THE PATIENT FELL SEVERAL MONTHS PRIOR TO REPORT, BUT HAD NOT FALLEN RECENTLY. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING PAIN. THE PATIENT HAD A GRANULOMA AT THE END OF THE CATHETER. THE PATIENT'S HEALTHCARE PROVIDER WAS IN THE PROCESS OF LOWERING THE PATIENT'S PUMP DOSAGE; THEY HAD STARTED 3 WEEKS TO A MONTH AGO. THE PLAN WAS TO HAVE THE PATIENT DELIVER MEDICATION VIA HIS PERSONAL THERAPY MANAGER (PTM) ONLY TO GET THE GRANULOMA TO GO AWAY ON ITS OWN. THEY HAD ALSO DISCUSSED CHANGING THE MEDICATION IN THE PUMP TO SALINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CAUSE OF THE EVENT WAS 'DIFFICULTY VOIDING' AND THE EVENT WAS ATTRIBUTED TO THE CATHETER. A MAGNETIC RESONANCE IMAGE (MRI) IN (B)(6) 2012 CONFIRMED THE GRANULOMA ON THE CATHETER TIP. THE CATHETER WAS REVISED AND THE PATIENT WAS HOSPITALIZED FOR 23 HOURS FOR OBSERVATION. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30969 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R