BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3080349 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01177
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY REPORTED THE DATE INCORRECTLY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED FOR THE PATIENT'S REFERRAL FOR GENERATOR REPLACEMENT SURGERY. ON (B)(6) 2013, THE NURSE INTERROGATED THE PATIENT'S GENERATOR WHICH SHOWED AN IFI CONDITION (INTENSIFIED-FOLLOW-UP CONDITION), BUT SHE WAS UNABLE TO OBTAIN DEVICE DIAGNOSTICS. FOLLOW-UP WITH THE TREATING NURSE REVEALED THAT SHE WAS LIKELY TRYING TO PERFORM GENERATOR DIAGNOSTICS WHICH MANUFACTURER LABELING RECOMMENDS TO ONLY PERFORM IN THE OPERATING ROOM TO TEST THE FUNCTION OF THE GENERATOR. THIS TEST IS NOT SUPPOSED TO BE PERFORMED IN THE CLINICAL SETTINGS. IT IS UNKNOWN WHAT MESSAGE WAS OBTAINED ON THE HANDHELD. THE NURSE WAS PROVIDED TRAINING REGARDING HOW TO PERFORM DIAGNOSTICS. SHE WAS UNABLE TO OBTAIN DIAGNOSTICS ON THE DEVICE ON (B)(6) 2013 WITH TWO DIFFERENT HANDHELDS AND WANDS. HOWEVER, THE PROGRAMMING SYSTEMS ARE FUNCTIONING PROPERLY SINCE THIS EVENT. THE NURSE REPORTED THAT SHE DETERMINED THAT THE UNIT IS FUNCTIONING PROPERLY, APPROPRIATE CARE DECISIONS WERE MADE AND THAT SHE NOW UNDERSTANDS THE DIAGNOSTIC PROCEDURES. DIAGNOSTICS ON (B)(6) 2013 WERE WITHIN NORMAL LIMITS. IT APPEARS THAT THE INABILITY TO PERFORM DIAGNOSTICS ON (B)(6) 2013 MAY HAVE BEEN USER RELATED. THE PATIENT HAS NOT BEEN EVALUATED BY THE NURSE AGAIN SINCE (B)(6) 2013, BUT SHE HAS BEEN REFERRED TO NEUROSURGERY. ALTHOUGH PROPHYLACTIC GENERATOR REPLACEMENT SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THE GENERATOR WAS COMPLETED. THE REPORTED FAILURE TO PROGRAM ALLEGATION WAS NOT DUPLICATED IN THE LAB. THE PULSE GENERATOR WAS INTERROGATED AT MULTIPLE ORIENTATIONS ADJACENT TO THE PROGRAMMING WAND, WITH A ONE INCH SPACER BETWEEN THE PULSE GENERATOR AND THE PROGRAMMING WAND. THE PULSE GENERATOR INTERROGATED AT ALL ORIENTATIONS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.804 VOLTS AS MEASURED DIAGVBAT OF THE FINAL ELECTRICAL TEST, SHOWS A NON-IFI CONDITION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE AT THE PHYSICIAN'S OFFICE INDICATING THAT THERE WAS NO SUSPECTED GENERATOR ISSUE, BUT IT WAS A "BATTERY ISSUE." NO OTHER DIAGNOSTIC TESTS WERE PERFORMED AFTER (B)(6) 2013 UNTIL DATE OF GENERATOR REPLACEMENT ON (B)(6) 2013 AT WHICH TIME LEAD TEST SHOWED "GOOD IMPEDANCE." THE PATIENT HAD PROPHYLACTIC GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. THE EXPLANTED GENERATOR WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2013. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. THE RETURN PRODUCT FORM INDICATED THE REASON FOR REPLACEMENT AS END OF SERVICE (BATTERY DEPLETION), BUT THE NEAR END OF SERVICE INDICATOR WAS NOT MARKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181270 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201065

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR