BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4157437 · Received October 9, 2014

    Report

    Report Number
    3004209178-2014-18626
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    September 19, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STIMULATOR SERIAL NUMBER (B)(4) FOUND SETSCREW BACKED OUT TOO FAR. ANALYSIS REVEALED NON-SIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD LOT NUMBER V881399 FOUND THE LEAD BODY CONDUCTORS BROKEN AT OR NEAR TINES. ALL CONDUCTORS WERE BROKEN AT 4.9 CENTIMETER FROM THE DISTAL END. THE PREVIOUSLY REPORTED CONCLUSION CODE 67 NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V881399, IMPLANTED: (B)(6) 2012, 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 THE PATIENT HAD PAINFUL SHOCKING SENSATIONS WHEN THE NURSE PROGRAMMED HIM. ABNORMAL IMPEDANCES, GREATER THAN 4,000 OHMS, WERE READ ON ALL ELECTRODE COMBINATIONS. THE PATIENT TOLD HIS NURSE THAT HE FELL AT THE BOWLING ALLEY, WHICH COULD BE A POSSIBLE CAUSE. HE ALSO EXPERIENCED LESS THAN 50% THERAPY RELIEF AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPORTED TO BE BROKEN. THE NURSE TURNED THE DEVICE OFF AND THE PLAN WAS TO EXPLANT AND POSSIBLY REPLACE THE SYSTEM. THE FINAL INTERVENTION AND PATIENT OUTCOME WERE NOT REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT HAD A REVISION SURGERY DONE ON (B)(6) 2014. IT WAS NOTED THAT THE LEAD PLACEMENT LOOKED NORMAL. IMPEDANCE CHECK WAS PERFORMED WHEN THE PATIENT WAS ASLEEP SINCE HE WAS UNABLE TO TOLERATE IT WHILE AWAKE, ALL COMBINATIONS WERE GREATER THAN 4000. THE PATIENT DOES NOT RECALL A FALL OR ANY TRAUMATIC EVENT TO CAUSE LEAD FRACTURE. HE HAS A NEW LEAD AND NEW STIMULATOR. HE HAD GREAT SENSATION AN AMPLITUDE OF 1.4 VOLTS. THE PATIENT WAS DOING WELL POST OPERATIVE, TOO SOON TO KNOW ABOUT SYMPTOM RELIEF.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE SPOKE WITH THE NURSE AND THE PATIENT WAS REPORTED TO BE FINE SINCE TURNING OFF THE DEVICE. THE PATIENT IS BEING SEEN BY THE PHYSICIAN IN NOVEMBER AND REVISION WILL BE CONSIDERED. A SUPPLEMENTAL REPORT WILL BE SENT SHOULD ADDITIONAL INFORMATION BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634120 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention