NVM5

Description of Event or Problem

IT WAS REPORTED THAT IT HAS BEEN DISCOVERED THAT THE NEEDLE ALLOY IN THE NUVASIVE DUAL NEEDLE ELECTRODE SETS CONTAIN NICKEL WHICH IS NOT IDENTIFIED ON THE LABEL. A PATIENT UNDERGOING A SPINAL PROCEDURE HAD AN ANAPHYLAXIS REACTION TO THE PRODUCT. THE REPS WERE MADE AWARE OF NICKEL ALLERGY IN TEAM BRIEF BY ANESTHETIST RAISING QUESTIONS ABOUT NEEDLES AND NICKEL CONTENT. THE REP MADE CALLS TO GET CERTAINTY OF PRESENCE OF NICKEL. ULTIMATELY THE TEAM USED THE GEL ELECTRODE PATCHES, NOT THE NEEDLES, AND MOVED THE NVM5 UNIT FROM QE TO USE WITH GEL PATCHES, AS THEY WOULD NOT STRETCH TO THE PULSE MACHINE AT THE HOSPITAL. THE PT WAS UNDER ANAESTHETIC WAITING BEFORE NVM5 UNIT ARRIVED - ESTIMATED EXTRA 20 MINS ANAESTHETIC TIME. ONLY GEL PATCH ELECTRODES WERE USED FOR THE CASE, AND NO NEEDLES WERE INSERTED INTO PATIENT.

Additional Manufacturer Narrative

THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.