BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4192695 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20163
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0E0WN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED A LESION ON HIS BACK NEAR THE LEAD INSERTION SITE. THE PATIENT HAD SURGERY AND THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) EXCISED THE LESION ON THE DAY OF THE REPORT. THE LEAD WAS RIGHT BELOW THE LESION. THE LESION WAS CUT INTO, APPEARED TO BE MADE OF SOFT TISSUE, AND NO FLUID WAS PRESENT. THE HCP DID NOT THINK IT WAS A STITCH GRANULOMA AND SENT THE LESION TO PATHOLOGY FOR TESTING. THE HCP RE-TUNNELED THE LEAD AND REPLACED THE INTERNAL NEUROSTIMULATOR (INS) FOR ANTI-INFECTION MEASURES. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE HEALTHCARE PROVIDER NOTED NO EVIDENCE OF INFECTION. DATE WAS NOTED AS (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672964 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention