BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2863830 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11334
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V391132, IMPLANTED: 2010 (B)(6), EXPLANTED: 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

    IT WAS REPORTED THAT THE PATIENT'S DEVICE AND PART OF THE LEAD WERE EXPLANTED ON (B)(6) 2012. THE REPORTER STATED THAT THE DOCTOR WAS UNABLE TO REMOVE THE "TINED" PORTION OF THE LEAD AND IT WAS LEFT IN THE PATIENT. IT WAS STATED THAT THE DEVICE NEVER WORKED FROM "GET-GO." THE REPORTER STATED THAT WHEN SHE WOULD TURN UP THE DEVICE, SHE WOULD GET SHOCKING IN THE FEET. AS A RESULT, THE PATIENT STATED THAT SHE NOW HAD PERMANENT "DEAD NERVES" IN THE SPINE. IT WAS STATED THAT THE PATIENT WAS IN PAIN ALL THE TIME. IT WAS ALSO STATED THAT THE DEVICE WAS IMPLANTED TOO CLOSE TO THE SKIN. IT WAS NOTED THAT THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) WANTED TO REPOSITION THE DEVICE, BUT THE PATIENT STATED "NO" AND WANTED THE DEVICE REMOVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS WORKING WITH THE PATIENT AND THE HCP TO SCHEDULE AN APPOINTMENT FOR THE REMOVAL OF THE REMAINING PORTION OF THE LEAD. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) FOR THE REMOVAL OF THE DEVICE DUE TO COMPLAINTS OF PAIN AT THE BATTERY SITE. THE REPORTER STATED THAT THERE WAS NEITHER ANY MENTION OF SPINAL PAIN NOR THE DEVICE SHOCKING THE PATIENT IN HER CHART. UPON REMOVAL OF THE IMPLANTABLE NEUROSTIMULATOR, THE SITE DID NOT SHOW ANY SIGNS OF INFECTION OR IRRITATION. THE REPORTER STATED THAT THE HCP INFORMED THE PATIENT PRIOR TO DEVICE REMOVAL THAT NOT "ALL PIECES" OF THE DEVICE COULD BE REMOVED, BUT AN ATTEMPT WAS GOING TO BE MADE. THE PATIENT WAS REPORTEDLY SEEN FOR POST-OPERATIVE VISITS "A FEW TIMES" AFTER THE DEVICE WAS REMOVED AND SHE DID NOT HAVE ANY COMPLAINTS OF PAIN AND "SEEMED HAPPY" TO HAVE HAD THE DEVICE REMOVED. THE HCP DID NOT SEE ANY CLINICAL INDICATION FOR PAIN AT THAT VISIT IN RELATION TO THE EXPLANTED DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THE PATIENT COULD NOT HAVE AN MRI DUE TO THE TINE PORTION OF THE LEAD REMAINING IN THEIR BODY. IT WAS ALSO NOTED THAT THE THERE WAS NO MENTION OF NERVE DAMAGE IN THE DOCTOR¿S CHART.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R