BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2381756 · Received December 19, 2011

    Report

    Report Number
    3007566237-2011-09290
    Event Type
    Injury
    Date Received
    December 19, 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

    Additional Manufacturer Narrative · 1

    (B)(4): WOUND DETACHMENT.

    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 11) WITH A PRIMARY PATHOLOGY OF CEREBRAL PALSY. PREOPERATIVE AND POSTOPERATIVE ASHWORTH SCORES WERE 4 AND 2, RESPECTIVELY. THE PATIENT EXPERIENCED WOUND DETACHMENT WHICH WAS MANAGED AND HEALED WITH HYPERBARIC THERAPY.

    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 00012 YR Required Intervention