BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2382609 · Received December 20, 2011

    Report

    Report Number
    3007566237-2011-09296
    Event Type
    Injury
    Date Received
    December 20, 2011
    Date of Event
    May 1, 2011
    Report Date
    December 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: PEKEL F, AYDIN S, ABUZAYED B, KUCUKYURUK B, HANIMOGLU H, TANRIVERDI T, ERHAN B, TEKEOGLU A, HANCI M. [INTRATHECAL BACLOFEN THERAPY FOR SPASTICITY: A SINGLE-INSTITUTION EXPERIENCE AND REVIEW OF THE LITERATURE]. TURK. FIZ. TIP REHAB. DERG. 2011;57(1):1-7. DOI: 10.4274/TFTR.57.01. SUMMARY: THE AUTHORS REPORT ON TWENTY-FIVE PATIENTS SUFFERING FROM SPASTICITY SECONDARY TO CRANIAL AND SPINAL PATHOLOGIES WERE TREATED BY ITB AND PUMP IMPLANTATION BETWEEN 2006 AND 2010. OF THESE PATIENTS, 18 WERE MALE AND 7 WERE FEMALE, WITH A MEAN AGE OF 34.4 YEARS (RANGE: 12-52 YEARS). THE AVERAGE FOLLOW-UP PERIOD WAS 20.3 MONTHS. PUMP LOADING AND DRUG INFUSION WERE STARTED IMMEDIATELY AFTER OPERATION OR ON POSTOPERATIVE DAY 1. THE INITIAL INFUSION RATE WAS 50 MCG/DAY FOR ALL PATIENTS. INFUSION RATE WAS GRADUALLY INCREASED BY 10% EVERY 5-7 DAYS UNTIL CLINICAL IMPROVEMENT WITHOUT SIDE EFFECTS WAS OBSERVED BY THE SURGEON AND THE PHYSIOTHERAPIST IN THE PATIENTS. DURING THIS PERIOD, THE USUAL ORAL MEDICATION WAS REDUCED GRADUALLY. REPORTABLE EVENT: THE AUTHORS REPORT ON A (B)(6) MALE (PATIENT 16) WITH A PRIMARY PATHOLOGY OF SPASTIC PARAPARESIS. PREOPERATIVE AND POSTOPERATIVE ASHWORTH SCORES WERE 4 AND 3, RESPECTIVELY. THE PATIENT SUFFERED FROM POSTOPERATIVE RESPIRATORY DIFFICULTY IN THE EARLY POSTOPERATIVE PERIOD BEFORE PUMP LOADING, WHICH REQUIRED FOLLOW-UP IN THE INTENSIVE CARE UNIT AND LATER EXTUBATION. IT WAS REPORTED THAT THIS COMPLICATION WAS UNRELATED TO THE CATHETER AS IT OCCURRED BEFORE PUMP LOADING AND DRUG INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| L| R