BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3093005 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07311
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 23, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V268042, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V268042, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE THE IMPLANT EXPLANTED BECAUSE IT HURT, COULD NOT HAVE AN MRI, AND PATIENT FELT SHE WAS BETTER WITHOUT IT. IT WAS INDICATED THAT "THERE IS NOT MUCH MORE THEY CAN DO."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE DEVICE NEVER PROVIDED HER WITH SYMPTOM RELIEF. IT WAS NOTED THAT THE DEVICE WAS REMOVED (B)(6) 2013 AND ¿A PIECE BROKE OFF¿ NEAR THE PATIENT¿S SPINE. THE REPORTER STATED THAT THE PATIENT¿S DOCTOR TOLD HER THAT IT COULD NOT BE REMOVED OR ACCESSED BECAUSE IT WAS LODGED IN TOO DEEP. IT WAS REPORTED THAT THE PATIENT WAS GIVEN MIXED MESSAGES ABOUT IF SHE COULD HAVE AN MRI OR NOT WITH THE BROKEN PIECE OF LEAD WIRE LEFT INSIDE HER BODY. IT WAS NOTED THAT THE PATIENT WAS UPSET THAT HER DOCTOR NEVER TOLD HER THAT SHE COULD NEVER HAVE AN MRI AGAIN AFTER HAVING THE DEVICE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE DEVICE WOULD BE EXPLANTED SO THAT THE PATIENT COULD HAVE AN MRI. EXPLANTATION WAS SCHEDULED FOR (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BECAUSE THE PATIENT HAD A LACK OF EFFECT SINCE IMPLANT AND IT NEVER WORKED FOR HER SYMPTOMS AT ALL, SHE TURNED THE DEVICE OFF FOR MONTHS. SHE HAD PAIN WITH EXERCISE WHILE IT WAS IMPLANTED. SHE DECIDED TO HAVE THE DEVICE REMOVED AND DURING EXPLANT, THE DOCTOR BROKE AN INCH AND A HALF PORTION OF THE LEAD AND WAS UNABLE TO REMOVE IT FOR UNKNOWN REASONS. THE PATIENT WAS UPSET BECAUSE SHE COULDN'T HAVE AN MRI AND NO OTHER SURGEONS WOULD TOUCH HER "BECAUSE OF THE RISK."

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR AND SYSTEM REMOVED ON (B)(6) 2013. IT WAS NOTED THAT THE DEVICE WAS HELPFUL FOR THE FIRST WEEK AFTER THE IMPLANT BUT AFTERWARDS THE PATIENT WOULD HAVE SYMPTOMS REGARDLESS IF THE DEVICE WAS ON OR OFF. IT WAS NOTED THAT THE PATIENT'S TRIAL WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195330 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R