BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1161184 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05761
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: MILPIED-HOMSI B, BERNIER C, MEGNIER M, STALDER J-F. [RETICULATED TELANGIECTASTIC ERYTHEMA FOLLOWING MORPHINE PUMP IMPLANTATION]. ANN DEMATOL VENEREOL. 2008;135(2):116-118. RETICULATED TELANGIECTATIC ERYTHEMA IS A CUTANEOUS COMPLICATION REPORTED AFTER THE IMPLEMENTATION OF PACEMAKERS AND CARDIAC DEFIBRILLATORS. HERE WE REPORT A CASE OCCURRING AFTER THE IMPLANTATION OF A MORPHINE PUMP. REPORTABLE EVENT: A MAN WAS FOLLOWED-UP ON IN A 'PAIN CENTRE" FOR LOWER BACK PAIN SECONDARY TO NUCLEUS PULPOSUS HERNIATION. MORPHINE PUMP TREATMENT HAD BEEN ADMINISTERED SINCE 1999 AND REPLACED AT THE SAME SITE IN 2004. THE PATIENT DEVELOPED LESIONS, WHICH OCCURRED THREE WEEKS TO THREE MONTHS AFTER IMPLANTATION OF THE DEVICE. THIS WAS A CASE OF POORLY DELINEATED, NON-INFILTRATED, SLIGHTLY SYMPTOMATIC (OCCASIONALLY SLIGHTLY PRURIGINOUS) ERYTHEMA SUBSEQUENTLY DONNING A REDDISH BROWN APPEARANCE AND COVERED WITH TELANGIECTASIA IRRIDATING DISTALLY, THUS GIVING A RETICULATED APPEARANCE TO THE RASH. ALLERGY TESTING WAS NEGATIVE. GIVEN THE PERSISTENCE OF THE LESIONS COUPLED WAS DISCOMFORT, THE PATIENT ASKED FOR THE PUMP TO BE REMOVED. THIS WAS CARRIED OUT IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other PROGRAMMER MODEL UNK N=1| CATHETER MODEL UNK N=1| IMPLANTABLE INFUSION PUMP MODEL 8627 N=1