BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2883274 · Received December 21, 2012

    Report

    Report Number
    1644487-2012-03441
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    January 1, 2007
    Report Date
    December 4, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE, LOT NUMBER, EXPIRATION DATE, CORRECTED DATA: THE INITIAL REPORT DID NOT REPORT THIS PRODUCT INFORMATION AT THAT TIME. DEVICE MANUFACTURE DATE, CORRECTED DATA: THE INITIAL REPORT DID NOT REPORT THE MANUFACTURER DATE AT THAT TIME.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: THE SUPPLEMENTAL REPORT #1 INADVERTENTLY REPORTED THE DATE THE INFORMATION WAS RECEIVED BY THE MANUFACTURER INCORRECTLY. THE CORRECT DATE FIELD WAS (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE IMPLANTING SURGEON REVEALED THAT FROM THE GENERATOR REPLACEMENT IN 2008 THERE WAS NO MENTION OF A SUTURE BEING USED IN THE OPERATIVE NOTE OF USE OF SUTURE TO SECURE THE GENERATOR TO THE FASCIA. TRAINING WAS PROVIDED TO THE SURGEON'S OFFICE REGARDING LABELING RECOMMENDATIONS THAT A NON-ABSORBABLE SUTURE BE USED TO SECURE THE GENERATOR TO PREVENT SUCH OCCURRENCES OF GENERATOR MIGRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR VNS EXPLANT DUE TO AN UNKNOWN REASON. UPON FURTHER FOLLOW-UP, THE NURSE AT THE TREATING PHYSICIAN'S OFFICE REPORTED ON (B)(6) 2012 THAT THE PATIENT'S DEVICE IS BEING SCHEDULED FOR EXPLANT BECAUSE IT WAS TURNED OFF SOME TIME AGO FOR AN UNCLEAR REASON. SHE THOUGHT IT MAY HAVE BEEN DUE TO A LOW HEART RATE. FOLLOW-UP WITH THE NURSE REVEALED THE PATIENT HAD GENERATOR REPLACEMENT ON (B)(6) 2001, AND ON (B)(6) 2001, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH LOW SODIUM OF 120 ON CARBAMAZEPINE AND LEVETIRACETAM. SHE WAS TAKEN OFF CARBAMAZEPINE, AND WAS READMITTED ON (B)(6) 2001, WITH COGNITIVE ABNORMALITIES ON LEVETIRACETAM AND PHENYTOIN. SHE HAS A HISTORY OF EPISODIC TACHYCARDIA AND IS ON BETABLOCKER SINCE 2007. PATIENT WAS STARTED ON LTG IN 2008, AND THE VNS WAS TURNED OFF ON (B)(6) 2008, DUE TO TACHYCARDIA WITHOUT UNDERLYING CAUSE. PER THE NURSE, AFTER HAVING HER DEVICE TURNED OFF FOR SEVERAL YEARS, THE "EPISODIC TACHYCARDIA REMAINS UNEXPLAINED, BUT SHE IS TAKING A BETA BLOCKER". A NOTE FROM THE CARDIOLOGIST DATED (B)(6) 2008, STATED THAT THE PATIENT'S SEIZURE MEDICATIONS WERE REDUCED AND SHE HAD ONE SIGNIFICANT SEIZURE EPISODE. SINCE THEN, SHE HAD MORE PALPITATIONS AND SOME VAGUE CHEST PAIN. PATIENT RETURNED ON THIS DAY FOR A FOLLOW-UP DUE TO RECENT INCREASE FREQUENCY OF PALPITATIONS. PATIENT HAD EPISODES OF SEIZURES ABOUT EVERY TWO TO THREE WEEKS, AND IT WAS NOTED THAT THE PATIENT HAD A VAGAL NERVE STIMULATOR PLACED. AFTER THE SEIZURE EPISODES, THE PATIENT HAD PALPITATIONS USUALLY AT NIGHT AND LASTED FOR LESS THAN MINUTES, MOST CONSISTENT WITH PROBABLE PREMATURE BEAT FEELINGS. THE METOPROLOL SODE WAS INCREASED TO "25 MG DAILY FOR PAC OR INAPPROPRIATE SINUS TACHYCARDIA SUPPRESSION. SHE ALSO HAD SOME VAGUE CHEST PAIN AND WAS INITIATED FOR CAD EVALUATIONS. SHE ALSO HAS SOME EXERTIONAL FATIGUE. OTHERWISE, SHE DENIED ANY OTHER CARDIAC-RELATED COMPLAINTS". ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP WITH THE NURSE WAS PERFORMED WHO REPORTED THAT THE DETAILS REGARDING THE EVENTS ARE NOT REMEMBERED. THE PATIENT WAS COMPLAINING AND BEING TREATED FOR TACHYCARDIA. THE VNS WAS TURNED OFF FOR AN MRI ON (B)(6) 2008, AND THE PATIENT HAD IT TURNED BACK ON (B)(6) 2008 REPORTEDLY. WHEN TRYING TO TURN THE OUTPUT CURRENT ON, THE NURSE REPORTEDLY "COULD NOT GET THE OUTPUT PAST 0.75MA" DUE TO EXTREME COUGHING. ALTHOUGH THE PREVIOUS OUTPUT CURRENT WAS 2.0MA, THE SITE ATTEMPTED TO TURN THE CURRENT TO 1.75MA BUT THE PATIENT EXPERIENCED VIOLENT COUGHING. CURRENT DECREASED TO 1.5MA WITH ON TIME EVERY 3 MINUTES AND OFF TIME AT 1.8 MINUTES. THE SETTINGS WERE NOT TOLERATED, AND CONTINUED TO NOT BE TOLERATED AT 1.25MA. CURRENT WAS THEREFORE DECREASED. DUE TO THE TACHYCARDIA, THE VNS WAS TURNED OFF SOON AFTER PER THE NURSE (WHICH WAS OBSERVED ON (B)(6) 2008). LATER ON (B)(6) 2009, THE NOTES INDICATED THAT THE DEVICE HAD BEEN TURNED OFF WITH NO EXACERBATION OF SEIZURES OVER 6 MONTHS. PATIENT REQUESTED TO HAVE THE DEVICE REMOVED FOR REASONS OF PAIN AND DISCOMFORT AT NIGHT. PATIENT WAS REFERRED FOR SURGICAL CONSULT FOR VNS EXPLANT. NOTES DATED (B)(6) 2009 REVEALED THAT THE PATIENT REQUESTED TO HAVE VNS REMOVED, "AS IT HAS NOT BEEN HELPING AND IS SOMEWHAT UNCOMFORTABLE MOVING AROUND IN THE POCKET".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 303

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention