BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1884592 · Received October 19, 2010

    Report

    Report Number
    3007566237-2010-08096
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 15, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD WITHDRAWAL SYMPTOMS DURING THE NORMAL REFILL CYCLE. WHOLE BODY, SEVERE SPASTICITY RETURNED. THE PT HAD JUST RETURNED HOME FROM A FIVE DAY STAY AT HOSPITAL (PT ENTERED HOSPITAL ON (B)(6) 2010). CALLER INDICATED THIS WAS THE SECOND TIME THIS HAS OCCURRED TO PT WITHIN THE LAST TWO MONTHS. PT'S LAST HOSPITAL STAY WAS (B)(6) 2010 (ALSO FOR 5 DAYS). WITH BOTH OCCURRENCES, PT STARTED SHOWING SIGNS OF INCREASED SPASTICITY 4-5 DAYS PRIOR TO BEING ADMITTED TO HOSPITAL. REGARDING THE (B)(6) VISIT, PT'S DOSAGE WAS INCREASED TO 210 MCG/DAY A FEW DAYS BEFORE HOSPITALIZATION. THERE WERE NO CHANGES IN DOSAGE PRIOR TO (B)(6) 2010 HOSPITALIZATION. PT WAS GIVEN ORAL BACLOFEN TO HELP COMBAT THE WITHDRAWAL EFFECTS. PT WAS CURRENTLY BEING WEANED OFF THE ORAL AND WAS MAINTAINING WELL WITH WEANING. AFTER THE (B)(6) HOSPITALIZATION A DYE STUDY WAS PERFORMED AND NO PROBLEM WAS FOUND. IMAGING WAS PERFORMED AFTER THE (B)(6) EVENT AND NO PROBLEM WAS FOUND. AFTER THE (B)(6) HOSPITALIZATION THEY CHECKED THE PUMP FOR THE AMOUNT OF MEDICATION AND COMPARED WHAT THE EXPECTED AMOUNT SHOULD BE AND IT MATCHED UP. NO DIAGNOSTIC TESTING WAS PERFORMED ON THE PT FOR THE (B)(6) HOSPITALIZATION. 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
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R ACCESSORY: MODEL 8590-1, LOT# N148399| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N168508014| IMPLANTED: