BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4090885 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17061
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    September 12, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# VA0KXCE, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V842532, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LESS RELIEF FROM SYMPTOMS THAN WHEN THE LEAD WAS ON THE RIGHT SIDE (REPLACEMENT LEAD PLACED ON THE LEFT SIDE). IT WAS REPORTED LATER (B)(6) 2014 THAT APPROXIMATELY IN MAY OF THIS YEAR; A NEW SYSTEM WAS PUT ON THE LEFT SIDE (RIGHT SIDE LEAD STILL REMAINED). THE PATIENT STATED SHE WAS EXPERIENCING SCIATIC PAIN EVEN WITH GENERATOR TURNED OFF AND THE CONCLUSION WAS THE LEAD WAS TOUCHING ONE OF THE NERVES AND THAT WAS PROVIDING HER WITH PAIN THOUGH SHE STILL GETTING SYMPTOM RELIEF. CALLER STATED PATIENT INDICATED THAT THE PAIN CAN BE UNBEARABLE IN CERTAIN POSITIONS. CALLER REPORTED 2 DAYS LATER FROM PREVIOUS CALL THAT HE PROVIDED FEEDBACK TO THE HEALTH CARE PROVIDER REGARDING REMOVING THE LEAD AND REPLACING IN THE SAME SIDE TO SEE IF A DIFFERENT LEAD TRACK WOULD REDUCE THE SCIATIC PAIN. SCIATIC PAIN WAS PRESENT SINCE THE REPLACEMENT IN (B)(6). CALLER REPORTED THE HEALTH CARE PROVIDER DID NOT WANT TO DO THAT BECAUSE THEY THINK THE PATIENT¿S ANATOMY WAS DIFFERENT AND WANTED TO GO BACK TO THE RIGHT SIDE WHERE THERE WAS AN EXISTING LEAD FRAGMENT FROM PREVIOUS REMOVAL. CALLER REPORTED THEY TRIED ALL DIFFERENT PROGRAMMING OPTIONS WITH STIM ON AND OFF THE SCIATIC PAIN WAS STILL PRESENT. IT WAS LATER REPORTED ON (B)(6) 2014, THE WHOLE SYSTEM WAS REMOVED FROM THE LEFT SIDE. THE SURGERY WAS SUCCESSFUL. THE PATIENTS' SCIATIC PAIN HAS DISSIPATED BUT NOT COMPLETELY TO MY UNDERSTANDING. THE PATIENT WAS NOT CURRENTLY RECEIVING SACRAL NERVE MODULATION (SNM) THERAPY. MANUFACTURER REPRESENTATIVE UNDERSTANDING WAS THAT AFTER THE PATIENT FULLY RECOVERS FROM THE SURGERY SNM THERAPY WILL BE RECONSIDERED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE SYSTEM WAS REMOVED ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE STIMULATOR AND THE LEAD WAS INVOLVED IN THE EVENT. THE PATIENT HAD MUCH PAIN ON THE LEFT SIDE TO THE POINT WHERE IT WAS REMOVED. THE LEAD AND THE BATTERY WAS REMOVED AFTER REPLACEMENT OF THE LEAD AND BATTERY. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568434 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention