BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4702614 · Received April 17, 2015

    Report

    Report Number
    3004209178-2015-07412
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    February 6, 2015
    Report Date
    March 27, 2015
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V913910, IMPLANTED: 2012 (B)(6), EXPLANTED: 2015 (B)(6); 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 ((B)(6) 2010).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TINED SECTION OF THE LEAD BROKE DURING EXPLANT. NO TROUBLESHOOTING WAS DONE TO PROVIDE INSIGHT TO THE ISSUE. THE PATIENT HAD THE REMOVAL DONE SO ANOTHER HCP COULD DO AN MRI. THE OTHER HCP WOULD NOT DO THE MRI BECAUSE 95 PERCENT OF THE PERMANENT LEAD WITH THE RETAINED DISTAL TIP WAS LEFT AND EVEN WITH INFORMATION FROM THE MANUFACTURER, RADIOLOGY WOULD NOT DO THE MRI. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) RECEIVED A CALL FROM THE PATIENT¿S SPOUSE REQUESTING THE MATERIALS OF THE LEAD. THE HCP HAD ATTEMPTED TO EXPLANT THE SYSTEM DUE TO THE PATIENT NEEDING AN MRI. THE HCP WAS ABLE TO EXPLANT ABOUT 95 PERCENT OF THE SYSTEM, BUT THE TINES WERE LEFT AS THE DISTAL LEAD TINES WERE RETAINED IN THE SACRUM. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257163 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Other