BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3790042 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08487
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 21, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID N EU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TAILBONE PAIN EVER SINCE THEIR URETHRAL SLING SURGERY. IT WAS NOTED THE PATIENT DID NOT FEEL STIMULATION. IT WAS REPORTED TURNING STIMULATION UP RESULTED IN STIMULATION IN THE TAILBONE AND NOT IN THE BICYCLE SEAT. IT WAS NOTED DECREASING STIMULATION DID NOT RESOLVE THE TAILBONE PAIN. IT WAS REPORTED THE PATIENT¿S STIMULATION WAS CONFIRMED ON. IT WAS NOTED TURNING STIMULATION OFF DID NOT RESOLVE THE TAILBONE PAIN. IT WAS REPORTED THE PATIENT¿S HEALTHCARE PROVIDER THOUGHT THE LEADS WERE FRACTURED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM WAS REPLACED ON (B)(6) 2014. IT WAS STATED THAT THE LEADS WERE BAD AND "THIS WAS HORRIBLE." IT WAS STATED THAT THE PATIENT HAD A CYSTOCELE AND RECTOCELE "BECAUSE THE LEADS WERE STARTING TO MIGRATE." THE REPORTER THOUGHT THE LEADS WERE MIGRATING BEFORE CYSTOCELE AND RECTOCELE. IT WAS FURTHER STATED THAT THE REPORTER DID NOT THINK THE LEADS "STAYED WHERE THEY WERE SUPPOSED TO WHEY THEY RETHREADED DOWN THE SAME TUNNELS... THEY REALLY SLIPPED DURING THE SURGERY." THIS CAUSED THE PATIENT SOME DISCOMFORT. THE SURGERY THE REPORTER WAS REFERRING TO WAS ON (B)(6) 2014 (CYSTOCELE/RECTOCELE SURGERY, MID-URETHRAL SLING WAS PLACED). THE PATIENT HAD "OPERATIONS THAT REALLY SCREWED HER UP" AND DURING THE SURGERY THE HEALTHCARE PROVIDER (HCP) FORGOT TO DO THE MID REGIONAL SLING. THE PATIENT HAD A HARD RECOVERY AFTER THE SLING WAS PLACED AND SHE WAS BED RIDDEN FOR 5 WEEKS.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT WHERE IT WAS NOTED THAT THE IMPEDANCES WERE FINE AND THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPROGRAMMED. THE PATIENT WAS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268488 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention