BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2493488 · Received March 15, 2012

    Report

    Report Number
    3007566237-2012-00557
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: BERNUZ, BENJAMIN, HAUDREY ASSIER, HELENE BISSERIEX, JEAN-BAPTISTE THIEBAUT, CELIA RECH, AND ALEXIS SCHNITZLER. "INTRATHECAL BACLOFEN PUMP: A FOREIGN-BODY REACTION CASE REPORT AND ITS SOLUTION." INTRATHECAL BACLOFEN PUMP: A FOREIGN-BODY REACTION CASE REPORT AND ITS SOLUTION 44.2 (2012): 184-85. PRINT SUMMARY: A (B)(6) WOMAN WITH CEREBRAL PALSY AND DISABLING SPASTICITY UNDERWENT A SERIES OF 4 IMPLANTATIONS OF INTRATHECAL BACLOFEN PUMPS, PERFORMED BY TWO TEAMS. A HISTORY OF 3 ASEPTIC LOCAL SKIN REACTIONS OVER THE SITE OF INSERTION STARTED 4 MONTHS AFTER THE FIRST INSERTION, ONCE WITH PARTIAL PUMP EXPOSURE. THERE WERE NO CLINICAL OR BIOLOGICAL SIGNS OF INFECTION. SKIN PATCH TESTS WERE NEGATIVE. RELOCATION OF THE SYSTEM WAS FOLLOWED BY A RELAPSE, WHILE REMOVAL OF THE PUMP WAS FOLLOWED EACH TIME BY COMPLETE RESOLUTION OF THE SYMPTOMS. HISTOLOGICAL FINDINGS SHOWED SLIGHT MONONUCLEAR DERMAL INFILTRATION WITHOUT EPIDERMAL LESIONS, WHICH EXCLUDED CONTACT DERMATITIS. PUMP INTOLERANCE WITH A FOREIGN-BODY REACTION WAS DIAGNOSED. A PUMP WRAPPED WITH POLYETHYLENE TEREPHTHALATE WAS REIMPLANTED. NO RECURRENCE OF SYMPTOMS OCCURRED AFTER A 3-YEAR FOLLOW-UP PERIOD, WITH IMPROVEMENT IN IMPAIRMENT, ACTIVITY AND SATISFACTION DUE TO INTRATHECAL BACLOFEN THERAPY. CONCLUSION: A FOREIGN-BODY REACTION AFTER INTRATHECAL BACLOFEN PUMP IMPLANTATION IS A RARE COMPLICATION, WHICH HAS NOT BEEN REPORTED PREVIOUSLY, AND WHICH IS ASSOCIATED WITH NEGATIVE SKIN PATCH TESTS. IN CASES WITH NO SIGNS OF INFECTION, SKIN INTOLERANCE MUST BE SUSPECTED AND DERMATOLOGICAL ASSESSMENTS SHOULD BE CARRIED OUT. REPLACEMENT WITH A PUMP WRAPPED IN AN INERT COATING IS AN EFFECTIVE AND AVAILABLE SOLUTION. REPORTED EVENT: IN (B)(6) 2007, SIX MONTHS AFTER THE PREVIOUS PUMP WAS EXPLANTED DUE TO INFECTION (SEE MFR REPORT #3007566237-2012-00556) A SECOND PUMP WAS IMPLANTED ON THE OTHER SIDE OF THE ABDOMINAL WALL. AFTER A TWO MONTH PERIOD, THE PATIENT EXPERIENCE PRURITIC ERYTHEMA OF THE SCAR, WITH NO SIGNS OF INFECTION EXCEPT FOR A SLIGHTLY RAISED CRP COUNT (13 MG/L), WHICH WAS IN A STEADY STATE. SKIN PATCH TESTS WERE PERFORMED TWICE, FIRST ON THE BACK, THEN ON THE ARM USING A COMPONENT SAMPLE SET OBTAINED FROM THE MANUFACTURER. THE RESULTS WERE NEGATIVE. THE PUMP WAS FINALLY REMOVED AND REPLACED WITH A POLYETHYLENE TEREPHTHALATE (PET)-WRAPPED PUMP, WHICH WAS APPROVED AND PROVIDED BY THE MANUFACTURER. NO RECURRENCE OF THE SKIN REACTION WAS OBSERVED DURING A FOLLOW-UP PERIOD OF 3 YEARS. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237-2012-00556.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention