BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2493337 · Received March 15, 2012

    Report

    Report Number
    3007566237-2012-00556
    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
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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." NEUROMODULATION 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) 2005 A (B)(6) WOMAN WAS IMPLANTED WITH AN INTRATHECAL BACLOFEN (ITB) PUMP ON THE RIGHT LUMBAR WALL AFTER A POSITIVE ITB TEST SHOWING IMPROVEMENT IN GAIT PARAMETERS AND LYING AND SITTING DISCOMFORT. FOUR MONTHS LATER ((B)(6) 2006) SHE DEVELOPED PAINFUL ERYTHEMA AROUND THE PUMP, WITH ADHERENCE AND PARTIAL PUMP EXPOSURE AWAY FROM THE SCAR. THE REACTION WAS THOUGHT POSSIBLY TO BE DUE TO THE MECHANICAL EFFECT OF FRICTION FROM THE WHEELCHAIR BECAUSE OF THE PUMP POSITION; THUS, THE PUMP WAS RELOCATED TO THE RIGHT LOWER PORTION OF THE ABDOMINAL WALL IN (B)(6) 2006. ONE MONTH LATER ((B)(6) 2006), THE SAME SKIN REACTION HAPPENED OVER THE SCAR, STILL WITH NO CLINICAL OR BIOLOGICAL SIGNS OF INFECTION. TOPICAL CORTICOSTEROIDS AND VITAMIN A WERE APPLIED "SUCCESSFULLY" FOR 10 DAYS, AFTER AN INFECTION SYMPTOM-FREE INTERVAL OF 1 MONTH, LEADING 1 WEEK LATER TO A REAL SCAR INFECTION WITH FEVER (38 C), CRP =19 THEN > 50 MG/L, NEUTROPHIL COUNT 9.6 X 10^9/L, AND THE PRESENCE OF (B)(6) ON SKIN CULTURE. THE PUMP WAS REMOVED IN (B)(6) 2006 AND ANTIBIOTICS WERE ADMINISTERED WITH GOOD RESULTS.

    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