BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3170257 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10387
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# V199904, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED "NO ANOMALY." FINAL ANALYSIS OF THE UNKNOWN LEAD REVEALED IT HAD A "BROKEN CONDUCTOR" DUE TO "OVERSTRESS/DAMAGE." FINAL ANALYSIS OF LEAD WITH LOT NUMBER V199904 REVEALED THE PRODUCT WAS "CUT THROUGH" AND "SEGMENTED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANT TODAY BECAUSE THE PATIENT WANTED AN MRI OF HER BACK. IT WAS NOTED THAT THE PHYSICIAN BROKE THE LEAD AND ALL ELECTRODES AND TINES WERE LEFT BEHIND IN THE PATIENT. THE LEAD REMOVAL WAS AT THE LEAD INTRUDER SITE, BUT DID NOT DISSECT DOWN. IT WAS QUESTIONED WHETHER IT WAS SAFE FOR THE PATIENT TO HAVE AN MRI. IT WAS INDICATED THAT THE PHYSICIAN WAS UNCOMFORTABLE RETRIEVING THE LEFT BEHIND COMPONENTS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR THE EXPLANT WAS LACK OF AFFECT WITH THE IMPLANT AND FUTURE NEED OF AN MRI. IT WAS NOTED THAT PRIOR TO PROCEDURE, THE PHYSICIAN DISCUSSED WITH THE PATIENT THE RISK OF LEAD REMOVAL AND LEAD FRACTURE. IT WAS INDICATED THAT THE PATIENT WAS ORIGINALLY IMPLANTED WITH BILATERAL LEADS. DURING REMOVAL OF THE PATIENT¿S LEFT LEAD, RESISTANCE WAS MET, THE PHYSICIAN CONTINUED DISSECTION TO FREE THE LEAD; HOWEVER, UPON LEAD REMOVAL THE LEAD FRACTURED LEAVING BEHIND ALL FOUR ELECTRODES. FURTHER DISSECTION WAS ATTEMPTED TO RETRIEVE REMAINING FRAGMENTS, BUT WAS UNSUCCESSFUL. DURING REMOVAL OF THE PATIENT¿S RIGHT LEAD, RESISTANCE WAS AGAIN MET, THE PHYSICIAN SUCCESSFULLY DISSECTED THE LEAD TO FREE TINES AND THE LEAD WAS EXPLANTED WITHOUT ISSUE. IT WAS NOTED THAT THE PHYSICIAN WAS GOING TO BE REFERRING THE PATIENT TO A NEUROSURGEON FOR ADDITIONAL EVALUATION/CONSULT REGARDING THE REMAINING LEAD FRAGMENTS. FURTHER INFORMATION RECEIVED REPORTED THAT THERE WERE NO DEVICE MALFUNCTIONS SUSPECTED OR DESCRIBED BY THE PATIENT. 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 THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272224 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other| R