Mi1210 SYNCHRONY ST +FLEX24 33186Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09008737331863), received between Nov 18, 2020 and Jul 13, 2023 — classified as 1 injury, 6 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 16, 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.

• MalfunctionJul 13, 2023Impedance Problem; Impedance Problem

  WHILE PLAYING A STONE FELL ON THE USER'S HEAD ON (B)(6) 2023. THE USER'S HEARING PERFORMANCE IS AFFECTED AND CHANNELS WITH ABNORMAL IMPEDANCE WERE FOUND. REVISION SURGERY WAS RECOMMENDED.

  Patient problems: Failure of Implant

  MAUDE report 17317417 ↗
• MalfunctionJul 7, 2023Migration; Migration

  A MESSAGE FROM THE USER ON THE MED-EL SOCIAL MEDIA BLOG WAS RECEIVED IN WHICH THE USER COMPLAINS ABOUT DIFFICULTIES IN HEARING WITH USING THE IMPLANT. THE USER REPORTS NOT TO BE ABLE TO HEAR VOICES, ONLY SOUNDS AND NOISES. THE USER ALSO REPORTS HEARING BELL LIKE RINGING SOMETIMES AND ALSO HEARS SOUNDS WHEN NOT WEARING THE AUDIO PROCESSOR OR WHEN TOUCHING HER PINNA.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276640 ↗
• MalfunctionJun 9, 2022Output Problem; Output Problem

  THE USER REPORTEDLY STOPPED RESPONDING TO SOUND WITH THE DEVICE SINCE MARCH 2022. THE FAMILY DID NOT REPORT A TRAUMA, FALL OR ASSOCIATION WITH ADVERSE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 14641221 ↗
• MalfunctionMar 30, 2022Output Problem; Output Problem

  THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS PLANNED FOR (B)(6) 2022, WHEN THE FAMILY RETURNS TO (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 13948536 ↗
• MalfunctionNov 9, 2021Output Problem; Output Problem

  ON (B)(6) 2020 THE USER WAS SEEN FOR A THERAPY SESSION WHERE GOOD PERFORMANCE ON THE LING SOUNDS WAS OBSERVED WITH NORMAL RESPONSES ON ALL CHANNELS. REPORTEDLY, IN (B)(6) 2021 COMMUNICATION SKILLS THROUGHOUT THE DEVICE WAS REPORTEDLY LOST UNTIL (B)(6) 2021 WHEN THE MOTHER ASKED FOR A REPAIRED AUDIO PROCESSOR. RE-IMPLANTATION HAS BEEN RECOMMENDED.

  Patient problems: Failure of Implant

  MAUDE report 12777519 ↗
• MalfunctionJan 15, 2021Migration

  THE USER IS EXPERIENCING FACIAL STIMULATION BUT NO AUDITORY STIMULATION ON CHANNELS 11 AND 12. THE USER ALSO FEELS A CURRENT IN THE TONGUE ON THESE CHANNELS. RE-IMPLANTATION IS RECOMMENDED BUT HAS NOT BEEN DECIDED UPON YET.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11176431 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS A TRAUMA TO THE HEAD RIGHT AFTER SURGERY AND THE SKIN BREACHED. THE WOUND SUBSEQUENTLY BECAME INFLAMED AND INFECTED. IN (B)(6)2020 THE CONCERNED DEVICE WAS EXPLANTED. NO NEW DEVICE WAS IMPLANTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 10859194 ↗

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-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-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. Mi1000 CONCE
• 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 Product