Nucleus Z43004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09321502002325), received between May 15, 2019 and Mar 21, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “No Device Output” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2023, DUE TO RECURRENCE OF CEREBELLOPONTINE ANGLE TUMOUR. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16580197 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED NON-AUDITORY SENSATIONS AND POOR PERFORMANCE WITH THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11106243 ↗
• InjuryApr 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED (DATE NOT REPORTED). ADDITIONAL INFORMATION WAS REQUESTED BUT NOT MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 10003566 ↗
• InjuryApr 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED (DATE NOT REPORTED). ADDITIONAL INFORMATION WAS REQUESTED BUT NOT MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 10003565 ↗
• InjuryMar 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO NON-USE.

  Patient problems: No Code Available

  MAUDE report 9845808 ↗
• InjuryJan 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE PATIENT'S SURGEON, THE PATIENT EXPERIENCED PAIN AND NON-AUDITORY SENSATIONS WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2018.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 9625069 ↗
• InjuryJul 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED NO SOUND AFTER A TRAUMA TO THE IMPLANT SITE. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Hearing Impairment

  MAUDE report 8829475 ↗
• InjuryJul 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED NO SOUND AFTER A TRAUMA TO THE IMPLANT SITE. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Hearing Impairment

  MAUDE report 8829474 ↗
• InjuryMay 15, 2019No Device Output; No Device Output

  PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REIMPLANTATION HAS BEEN SCHEDULED; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: Hearing Impairment

  MAUDE report 8614131 ↗