BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2930972 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01005
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# V973942, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR DOCTOR OR MEDTRONIC REPRESENTATIVE. IT WAS STATED, THE PATIENT HAD THEIR BATTERY SURGICALLY REMOVED ON (B)(6) 2013. APPROXIMATELY TWO WEEKS LATER, IT WAS REPORTED FROM THE HEALTH CARE PROVIDER (HCP) THAT THE CAUSE OF THE EVENT WAS DUE TO "EROSION" OF THE SKIN OVER THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE LEAD HAD ATTRIBUTED TO THE EVENT. WHEN THE HCP WENT TO REMOVE THE INS, HE DISCOVERED THAT THE LEAD TIP HAD MIGRATED FROM THE C3 FORAMEN TO A SUBCUTANEOUS POSITION. THE LEAD AND THE INS WERE BOTH EXPLANTED. THE PATIENT'S SYMPTOM WAS SKIN BREAK DOWN. THE PATIENT WAS NOT HOSPITALIZED AND HER OUTCOME WAS REPORTED AS NON-SERIOUS ILLNESS OR INJURY. NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD FOUR BLISTERS AT THE LOCATION OF HER STITCHES WHERE HER SKIN WAS OPEN FOLLOWING AN IMPLANT. IT WAS NOTED THAT THE PATIENT HAD SEEN HER DOCTOR. THE PATIENT WAS ON PROGRAM 3 AT 5.8 VOLTS, AND INCREASED FROM 3.6 VOLTS TO 5.8 VOLTS THE NIGHT BEFORE THE REPORT. A WEEK LATER, IT WAS REPORTED THAT THE PATIENT WAS "GOOD" FOR ONE MONTH FOLLOWING DEVICE IMPLANT, THEN FOR THE MONTH OR TWO PRIOR TO THE REPORT SHE GOT BLISTERS AROUND THE DEVICE SITE. IT WAS NOTED THAT THE PATIENT HAD BEEN ON ANTIBIOTICS TWICE AND HAD SEEN HER DOCTOR TWICE. THE REPORTER STATED THAT IT MAY BE CORROSION OF THE WIRE. IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW IF IT WAS AN INFECTION OR IF SHE WAS ALLERGIC TO THE DEVICE. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED TO HAVE SURGERY ON (B)(6) 2013 TO REMOVE THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37104 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention