Mi1000 MED-EL CONCERT PIN +COMPRESSED 06269Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09008737062699), received between Sep 3, 2019 and Dec 19, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (P000025); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Impedance Problem; Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED BUT THE CURRENT CONDITION OF THE COCHLEA IS UNCERTAIN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848466 ↗
• MalfunctionAug 14, 2023Impedance Problem; Impedance Problem

  IN THE MIDDLE OF (B)(6) 2023, THE USER STARTED TO LOSE THE HEARING BENEFIT FROM THE DEVICE. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 17539889 ↗
• MalfunctionJun 16, 2023Migration; Migration

  THE USER ATTENDED A PROGRAMMING VISIT SESSION ON (B)(6) 2023. SHE REPORTED THAT SINCE THE PREVIOUS SESSION SHE HAD BEEN UNABLE TO TOLERATE STIMULATION, DUE TO DISCOMFORT AND METALLIC TASTE SENSATIONS. HOWEVER, THE DEVICE ON THIS SIDE HAS NOT BEEN WORN FOR YEARS. WHILE RUNNING IN SITU TESTING, A STRONG METALLIC TASTE AND _BUZZING SENSATION_ TO THE RIGHT SIDE OF TONGUE WAS REPORTED. SENSATIONS WERE ALSO REPORTED THOUGH WHEN THERE WAS NO STIMULATION. LAST DIAGNOSTIC IMAGING IN (B)(6) 2022 REPORTEDLY ALREADY SHOWED MIGRATION OF DEVICE. ANOTHER CT SCAN HAS BEEN REQUETSED FOR CONCERNS OF FURTHER MIGRATION OF THE ELECTRODE ARRAY. ADDITIONAL VISIT SCHEDULED FOR (B)(6). THE USER IS CURRENTLY ADVISED TO NOT USE DEVICE GIVEN HER ADVERSE REPORTS WITH CURRENT MAPS (HAS ACTIVE ELECTRODES IN CURRENT MAPS THAT ARE EXTRACOCHLEAR) SHE IS FOLLOWING UP IN (B)(6). THERE IS NO PLAN OF REVISING AN OSSIFIED COCHLEA. NO FURTHER ACTION IS PLANNED ASIDE FROM PROGRAMMING SUGGESTIONS.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 17141835 ↗
• InjuryJun 10, 2021Output Problem; Output Problem

  THE USER NO LONGER HAD ANY HEARING SENSATION. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11974874 ↗
• InjuryOct 15, 2020Output Problem; Output Problem

  REPORTEDLY, HEARING PERFORMANCE WITH THE DEVICE HAS BEEN GRADUALLY AFFECTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10683825 ↗
• InjuryOct 16, 2019Output Problem; Output Problem

  RECIPIENT REPORTED NO SOUND FROM HIS PROCESSOR WHILE WATCHING TV. THERE WERE NO ADDITIONAL STRANGE SOUNDS OR UNUSUAL AUDITORY PERCEPTIONS. THERE IS NO REPORT OF AN ACCIDENT OR TRAUMA, NO CHANGES IN HEALTH OR SWELLING AT THE IMPLANT SITE REPORTED. THE USER WAS RE-IMPLANTED ON THE (B)(6) 2019. THIS REPORT REFERS TO 9710014-2019-00655. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 9195646 ↗
• InjurySep 3, 2019Output Problem; Output Problem

  RECIPIENT REPORTED NO SOUND FROM HIS PROCESSOR WHILE WATCHING TV AROUND (B)(6) 2019. THERE WERE NO STRANGE SOUNDS OR UNUSUAL AUDITORY PERCEPTS PRIOR TO THIS AND IT OCCURRED SUDDENLY. THERE WAS NO REPORT OF AN ACCIDENT OR TRAUMA, NO CHANGES IN HEALTH OR SWELLING AT THE IMPLANT SITE REPORTED. RE-IMPLANTATION WAS DECIDED AFTER AN UNREMARKABLE MEDICAL ASSESSMENT. THE RECIPIENT WAS RE-IMPLANTED ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 8956991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000025. One submission often covers many models, so check the product and lot details in each record.

• Z-2356-2024 · Apr 18, 2024 · Open, Classified
  Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
• Z-2136-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi100
• Z-2138-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used toge
• Z-2137-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard