BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3923602 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12749
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 19, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: ADDITIONAL REVIEW INDICATED DEVICE CODE C63038 WAS APPLICABLE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA090J8, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, 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 LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANTABLE NEUROSTIMULATOR (INS) REMOVAL PROCEDURE, THE LEAD BROKE. THE PATIENT WOULD LIKE MORE INFORMATION ABOUT THE LEAD REMAINING IN HER BODY. THE INS WAS REMOVED (B)(6) 2014. THE PATIENT WAS REPORTEDLY JUST INFORMED THE DAY PRIOR TO THE REPORT THAT THE LEAD BROKE DURING REMOVAL AND IT WAS INACCESSIBLE. THE PATIENT WAS UPSET THAT THE HEALTHCARE PROVIDER (HCP) WAITED 4 WEEKS TO TELL HER. THE ORIGINAL FOLLOW UP APPOINTMENT WAS SCHEDULED FOR 6 WEEKS AND BY THAT TIME ¿IT WOULD HAVE BEEN WORSE.¿ THE PATIENT WOULD ALSO LIKE A COPY OF SURGERY REPORT AND TO KNOW HOW MUCH LEAD WAS LEFT IN HER BODY. IT WAS MENTIONED THAT THE HCP DIRECTED THE PATIENT TO SEE A GENERAL PRACTICE HCP TO GET AN X-RAY. IT WAS REPORTED LATER THAT SAME DAY THAT THE PATIENT NOW HAD LEAD FRAGMENTS LEFT IN HER BODY AND THE PATIENT HAD LEG PAIN BECAUSE OF IT. THE HCP WAS REPORTEDLY ON VACATION AND WOULD SEE THE PATIENT UPON HIS RETURN. PLEASE REFER TO MFG. REPORT# 3004209178-2014-12736, AS IT PERTAINS TO THE REASONS FOR THE DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399464 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention