BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2698984 · Received August 15, 2012

    Report

    Report Number
    3004209178-2012-06893
    Event Type
    Injury
    Date Received
    August 15, 2012
    Report Date
    July 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V872900, SERIAL# IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYP LEAD PRODUCT ID, 3037 LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WOKE UP THREE DAYS EARLIER AT 3:00 AM IN PAIN AND NOTICED REDNESS AND BLISTERING AROUND THE AREA OF SPINE WHERE THE WIRES WERE LOCATED, OVER THE IMPLANT LOCATION, AND ON THE SIDE. THE PATIENT SAW HER HEALTH CARE PROFESSIONAL (HCP) THE NEXT DAY AND THE HCP STATED THAT SHE WAS ALLERGIC TO SOMETHING. THE NEXT DAY, THE PATIENT WENT TO ANOTHER PHYSICIAN WHO STATED THAT IT LOOKED BURNED. THE PATIENT'S BLISTERS HAD GONE AWAY BUT THEN OTHERS APPEARED. THE PATIENT HAD NOT SLEPT IN THREE DAYS. THE PATIENT HAD VOMITED TWICE. NO PAIN MEDICINE THAT HER PAIN DOCTOR PRESCRIBED WAS "TOUCHING HER DEVICE." THE PATIENT'S PAIN WAS IN THE BACK, HIP, AND DOWN THE LEGS. THE PATIENT WAS WORRIED SHE WASN'T URINATING ENOUGH. TWO HCPS RULED OUT SHINGLES. THE PATIENT HAD DIABETES AND CYSTITIS. FOR THE CYSTITIS THE PATIENT WOULD NORMALLY TAKE A SHOT EVERY DAY, HOWEVER, SINCE THE EVENT STARTED SHE HAD NOT TAKEN ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD BLISTERS ON HER "BOTTOM" AND PAIN AT HER IMPLANTABLE NEUROSTIMULATOR (INS) SITE; THE PATIENT'S PAIN HAD BEEN GETTING WORSE SINCE HER INS WAS IMPLANTED. THE PATIENT HAD NOT INFORMED HER PRIMARY PHYSICIAN OF THE PAIN. THE IMPLANTING PHYSICIAN DETERMINED THAT THE BLISTERS WERE NOT RELATED TO THE PATIENT'S INS SYSTEM AND SENT THE PATIENT TO A DERMATOLOGIST WHO TESTED HER SAMPLES AND CONCLUDED THAT THE BLISTERS ORIGIN WAS INDETERMINABLE. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention