BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3212398 · Received July 9, 2013

    Report

    Report Number
    9614453-2013-01468
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 13, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 64002, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 64002, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THEY WERE HAVING A CONTINUING ISSUE WITH HIGH IMPEDANCES. THE PATIENT¿S SYMPTOMS HAD RECURRED AND THE NEUROLOGIST HAD MEASURED HIGH IMPEDANCES FOR MOST OF THE LEAD CONTACTS. THE PATIENT WAS SCHEDULED FOR AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT ON (B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED DURING THE REVISION PROCEDURE THEY FOUND THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS OKAY. IT WAS DETERMINED THE IMPEDANCE PROBLEM WAS RELATED TO ONE OF THE PATIENT¿S OLD EXTENSIONS. IT WAS NOTED THE UNSTABLE IMPEDANCE MEASUREMENTS THEY HAD GOTTEN AT THE PREVIOUS REVISION WERE RELATED TO THE EXTENSIONS THAT WAS NOT TOTALLY DISCONNECTED. THE PATIENT HAD A BIG FAT LAYER IN THE POCKET AND THE INS THAT WAS NOT FIXATED WHEN DOWN AND PULLED THE EXTENSIONS. ONE OF THE EXTENSIONS WAS TOTALLY BROKEN AND THE OTHER WAS FINE. IT WAS NOTED BOTH OF THE LEADS WERE ALSO FINE. THE PHYSICIAN REPLACED THE EXTENSION AND FIXATED THE INS. ALL CONTACTS AND COMBINATIONS HAD GOOD IMPEDANCES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE THERAPY OF THE 0-3 LEAD IS FULL. THE THERAPY OF THE 4-7 LEAD HAS HIGH IMPEDANCES ON CONTACTS 5-6. THE PATIENT FEELS GOOD NOW. CONTACT NUMBER 4 AND THE CASE ARE ACTIVATED AS THE INITIAL PROGRAMMING WAS AFTER THE IMPLANTATION AND THE RESULTS ARE GOOD. THE PATIENT IS UNDER A CLOSE FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REPLACEMENT TO A NEW IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2012, ALTHOUGH IT WAS ALSO REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2012 AND IT IS UNCLEAR WHICH DATE IS CORRECT. IT WAS NOTED THAT BEFORE THE REPLACEMENT THE IMPEDANCES WERE FINE. IT WAS NOTED THAT AFTER THE REPLACEMENT THE IMPEDANCES STARTED TO BE PROBLEMATIC AND EVERY FEW WEEKS WHEN THE PATIENT MET WITH THE NEUROLOGIST, ANOTHER CONTACT HAD HIGH IMPEDANCES. IT WAS NOTED THAT FOLLOWING THE IMPEDANCE ISSUE, THERE WAS A REVISION OF THE POCKET ADAPTER ON (B)(6) 2013. IT WAS NOTED THAT IMPEDANCES REMAINED HIGH AFTERWARD. IT WAS FURTHER NOTED THAT IT WAS NOTICED THAT THE EXTENSION CONNECTION TRACK IN THE INS WAS FULL OF FAT. IT WAS NOTED THAT THE DOCTOR WASHED IT WITH A SYRINGE AND DRIED IT AND THE IMPEDANCES IMPROVED AT A FEW CONTACTS. IT WAS NOTED THAT THE POCKET OF THE INS LOOKED UNUSUAL AS IT WAS FULL OF LIQUIDS AND FATS. A SAMPLE WAS TAKEN TO CULTURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO INFECTION; IT WAS NOTED THAT IT WAS PROBABLY A FAT NECROSIS AT THE INS POCKET SITE. IT WAS NOTED THAT THERE WERE STILL ISSUES WITH IMPEDANCES; THE SECOND LEAD HAD CONTACTS 5 AND 6 WHICH WERE ¿NOT OKAY.¿ IT WAS REPORTED THAT AFTER THE REVISION THE PATIENT HAD EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313405 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention