BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4964138 · Received August 4, 2015

    Report

    Report Number
    3004209178-2015-14569
    Event Type
    Injury
    Date Received
    August 4, 2015
    Report Date
    October 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0L42C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD (L/N VA0L42C) FOUND THE CONDUCTOR WAS BROKEN 2.5CM FROM THE DISTAL END.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA0L42C, IMPLANTED: (B)(6 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# VA0L42C, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    THE CONSUMER AND MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS GETTING SHOCKS FROM THEIR DEVICE AND HAD UNCOMFORTABLE STIMULATION IN (B)(6) 2015. THE MANUFACTURER REPRESENTATIVE INTERROGATED THE SYSTEM AND IT LOOKED FINE. THEY TRIED DIFFERENT PROGRAMS, BUT ALL OF THEM GAVE THE PATIENT SHOCKS. THE DEVICE WAS HELPING THE PATIENT¿S SYMPTOMS. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REALLY SKINNY AND HAD PROBLEMS KEEPING THE LEAD IN PLACE. THE PATIENT WAS HAVING THEIR FOURTH SURGERY FOR REPLACEMENT AND WAS HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO THE INS NOT FUNCTIONING AND GETTING ELECTROCUTED. SURGICAL INTERVENTION WAS SCHEDULED FOR (B)(6) 2015. THE PATIENT STATUS AT THE TIME WAS ALIVE WITH NO INJURY. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. REFER TO MANUFACTURER¿S REPORTS # 3004209178-2012-12192 AND # 3004209178-2014-09170 FOR PRIOR 2 IMPLANTS BEING REPLACED DUE TO LEADS COMING OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE CONSUMER REPORTED THAT THE IMPLANT WAS ELECTROCUTING HER AND SHE TURNED BLACK AND BLUE FROM IT. THEY TOOK IT OUT AND PLACED A DIFFERENT IMPLANTABLE NEUROSTIMULATOR. IT WAS NOTED THAT THE SHOCKING STARTED IN (B)(6) 2015. THE PATIENT WAS NOT AROUND ANY HIGH SOURCES OF ELECTROMAGNETIC INTERFERENCE. NO FALL OR TRAUMA WAS NOTED. IT WAS NOTED THAT THE STIMULATOR MALFUNCTIONED. THERE WAS ZAPPING/ SHOCKING EXPERIENCED. IT WENT HIGH AND SHOCKED HER AND SHE COULD NOT GET IT TO COME ON OR ANYTHING. THEN IT DID IT AGAIN AND IT WAS PAINFUL. THERE WAS A SUDDEN CHANGE IN THERAPY/ SYMPTOMS. IT WAS UNKNOWN WHAT TROUBLE SHOOTING WAS PERFORMED RELATED TO THE SHOCKING SENSATION/ DEVICE MALFUNCTION. FURTHER INFORMATION FROM THE MANUFACTURER'S REPRESENTATIVE REPORTED THAT THE PATIENT WANTED A NEW SYSTEM DUE TO THE SHOCKS. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL RECEIVED BY THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD THEIR DEVICE EXPLANTED BECAUSE THE PATIENT WAS FEELING SHOCKING. THE REVISION OCCURRED (B)(6) 2015. PATIENT OUTCOME WAS UNKNOWN. THE INDICATIONS FOR USE (IFUS) WERE URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508100 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention