BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3899802 · Received June 27, 2014

    Report

    Report Number
    3007566237-2014-01806
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD REVISION WAS PERFORMED ON (B)(6)-2009. THE REPORTER STATED THAT THERE WERE NO OBSERVED DEVICE MALFUNCTIONS AND LEAD DISLODGEMENT WAS A WELL-KNOWN PROBLEM IN SACRAL NERVE STIMULATION. IT WAS NOTED THAT THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 1

    REIF, S., TILLER, M., HOFFMANN, E. UNCOMMON ETIOLOGY OF ABNORMAL SPIKES ON ELECTROCARDIOGRAM. JAMA INTERNAL MEDICINE. 2014; 174(3): 458-459. SUMMARY: A (B)(6) WOMAN WAS REFERRED TO OUR PACEMAKER/IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) CLINIC WITH AN ABNORMAL ELECTROCARDIO GRAM (ECG).THE ECG SHOWED ABNORMAL SPIKES COMPARED WITH A REGULAR ECG (WITHOUT SPIKES) OF THE SAME PATIENT PERFORMED 3 MONTHS EARLIER, PROMPTING A REFERRAL FOR DEVICE INTERROGATION. CLINICAL MANIFESTATIONS SUCH AS DIZZINESS, LIGHTHEADEDNESS, SYNCOPE, OR SIGNS AND SYMPTOMS OF CONGESTIVE HEART FAILURE WERE ABSENT. THE PATIENT¿S VITAL SIGNS WERE NORMAL. QUESTION: DO SPIKES ON ECG RESEMBLING IMPULSES PRODUCED BY A CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) NECESSARILY INDICATE A CARDIAC ETIOLOGY? REPORTED EVENT: A (B)(6) WOMAN HAD AN ¿ABNORMAL¿ ELECTROCARDIOGRAM (ECG), SHOWING ABNORMAL SPIKES. THE PATIENT HAD AN EGC 3 MONTHS EARLIER WITHOUT ARTIFACTS, SO THE PRESENCE OF THE SPIKES PROMPTED A REFERRAL FOR DEVICE INTERROGATION. THE PATIENT¿S VITAL SIGNS WERE NORMAL. ANALYSIS OF THE ABNORMAL ECG REVEALED VARIATIONS IN TIMING ATYPICAL FOR A CARDIAC DEVICE. A REVIEW OF THE PATIENT¿S MEDICAL RECORD REVEALED THE PRESENCE OF SACRAL NERVE STIMULATOR IMPLANTED 3 MONTHS EARLIER TO TREAT FECAL INCONTINENCE. THE BASELINE ECG PERFORMED AFTER SUCCESSFUL IMPLANTATION OF THE DEVICE SHOWED ABSENCE OF ARTIFACTS. PROPER LEAD PLACEMENT WAS BROUGHT INTO QUESTION DURING A ROUTINE TESTING OF THE DEVICE 6 DAYS BEFORE ADMISSION TO THE CLINIC. LEAD DISLODGEMENT WAS CONFIRMED ON RADIOLOGIC EVIDENCE OF ANTERIOR LEAD MIGRATION, WITH THE DISTAL TIP SUPERIMPOSED OVER THE HIP JOINT ON THE LATERAL VIEW. AFTER DETECTION OF LEAD DISLODGEMENT, SUCCESSFUL LEAD REVISION WAS PERFORMED. ECG ARTIFACTS WERE ABSENT AFTER REVISION. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: NEUROSTIMULATOR MODEL 3023 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377028 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 3023 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention