BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3821402 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09279
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA0B23D, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A "PYOGENIC GRANULOMA" AT LEAD AREA 1 MONTH AGO (3-18 SURGERY). REMOVED THAT AREA ¿SIZE OF A MARBLE¿. THE PATIENT HAS DEVELOPED A NEW GRANULOMA AGAIN. THE HEALTHCARE PROVIDER WAS QUESTIONING AN ALLERGY TO LEAD WIRE? NO ALLERGY TO STIMULATOR SITE. THE CALLER STATES THE PATIENT HEALTHCARE PROVIDER WAS WORKING WITH LOCAL REPRESENTATIVE AND MORE TESTING NEEDS TO BE DONE TO SEE WHAT THE PATIENT COULD BE ALLERGIC TO. THE PATIENT WAS TOLD THAT THERE WERE NO OTHER OPTIONS FOR MATERIAL CHANGES TO THE LEAD WIRE COMPONENTS. ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT STATES HE WAS WANTING TO KNOW WHAT MATERIAL THE LEAD WAS MADE OF AND IF THE PATIENT WAS ALLERGIC TO THE MATERIAL, WHAT COMES NEXT. THE PATIENT STATES HE WOULD LIKE THIS INFORMATION TO BE ABLE TO BRING BACK TO THE HCP(HEALTHCARE PROVIDER) TO DISCUSS. IT WAS REVIEWED WITH THE PATIENT THAT THERE ARE NO OTHER OPTIONS AS FAR AS THE LEAD GOES. A GRANULOMA WAS REPORTED. THE PATIENT HAD A GRANULOMA FORM ON THE LEFT GLUTEUS AREA WHERE THE LEAD WAS PLACED. THE PATIENT HAD GRANULOMA REMOVED ABOUT 1 MONTH AGO, ON (B)(6) 2014. THE PATIENT STATES THEY LEFT STITCHES IN FOR THE FIRST 10 DAYS AFTER THE GRANULATION TISSUE WAS REMOVED. THE PATIENT STATES ABOUT 1 WEEK LATER A LITTLE BIT OF TISSUE STARTED TO APPEAR IN THE EXCISION AREA. THE PATIENT STATES IT'S NOW GROWN TO THE SIZE OF A LARGE PEA OR SMALL MARBLE. THE PATIENT STATES HE WOULD LIKE TO KNOW IF THIS WAS RELATED TO THE TYPE OF MATERIAL THE LEAD WAS MADE OF. THE PATIENT WAS ALSO ON A NEBULIZER AND WOULD GET AN EARLOBE RASH OR FLAKING WITH CERTAIN TYPE OF JEWELRY SHE WOULD WEAR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD BECAME INFECTED AFTER IMPLANT. THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) REQUIRED REMOVAL, WHICH WAS ACCOMPLISHED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299416 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention