Mi1000 MED-EL CONCERT PIN +MEDIUM 06271Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09008737062712), received between Dec 16, 2020 and Feb 4, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Output Problem” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Impedance Problem

  THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO A DEFECTIVE ELECTRODE. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256834 ↗
• MalfunctionJul 6, 2023Impedance Problem; Impedance Problem

  THE USER WENT TO THE CLINIC FOR A ROUTINE MAPPING AND CHANGES IN TELEMETRY WERE DETECTED. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 17266245 ↗
• MalfunctionJul 3, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE FAMILY DOES NOT KNOW IF AN ACCIDENT OR TRAUMA HAS OCCURRED. THEY ALSO DON'T KNOW WHEN THE USER STOPPED HEARING WITH THE DEVICE AND IF IT WAS A SUDDEN STOP OR A GRADUAL DECREASE IN HEARING. A MEDICAL INTERVENTION IS CONSIDERED, BUT THE RE-IMPLANTATION IS NOT SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 17245641 ↗
• MalfunctionSep 20, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER MOTHER REPORTED THAT THE USER HAD A REGIONAL ERYTHEMA THREE DAYS AFTER A TRAUMA OVER THE DEVICE REGION. THE ERYTHEMA LASTED APPROXIMATELY THREE DAYS.

  Patient problems: Failure of Implant

  MAUDE report 15455353 ↗
• MalfunctionJan 20, 2022Output Problem; Output Problem

  REPORTEDLY, THE USER REPORTS INTERMITTENT HEARING PERFORMANCE WITH THE DEVICE IN DIFFERENT SITUATIONS SINCE LAST YEAR. THE USER HAS ANOTHER APPOINTMENT WITH THE CLINIC TO DISCUSS FURTHER PROCEEDING.

  Patient problems: Failure of Implant

  MAUDE report 13306225 ↗
• MalfunctionOct 25, 2021Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  ON THE (B)(6) 2021 THE USER EXPERIENCED ELECTRIC SHOCKS FROM HIS IMPLANT WHILE USING HIS SONNET AUDIO PROCESSOR. THE CHILD WAS SEEN ON (B)(6) 2021 BY A MED-EL REPRESENTATIVE AND THERE WAS NO SWELLING, SORENESS, OR REDNESS ABOVE THE IMPLANT SITE. A NEW AUDIO PROCESSOR PROGRAM WAS CREATED USING HIS FULLY FUNCTIONAL OPUS 2 AUDIO PROCESSOR. THE USER SHOWED NO SIGNS OF DISCOMFORT DURING FITTING AND AFTERWARDS FOR SEVERAL HOURS. HOWEVER, LATER THE SAME DAY, THE CHILD AGAIN EXPERIENCED AN ELECTRIC SHOCK. BEFORE THE EVENT OCCURRED, THE USER HAS USED HIS IMPLANT FOR MORE THAN 9 YEARS. HE HAD OPEN SET PERCEPTION AND HIGHLY INTELLIGIBLE SPEECH. IT IS PLANNED TO RE-IMPLANT THE USER.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12687723 ↗
• MalfunctionOct 14, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT IN SITU TESTING SHOWED ALTERED RESULTS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12632400 ↗
• MalfunctionSep 9, 2021Output Problem; Output Problem

  REPORTEDLY, THE USER NO LONGER HAD HEARING BENEFIT WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12446769 ↗
• InjuryFeb 24, 2021Output Problem; Output Problem

  THE USER'S PARENTS REPORT THAT THE CHILD WAS NOT HEARING ANYMORE USING THE DEVICE, SINCE (B)(6) 2020. THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11371524 ↗
• InjuryDec 16, 2020Output Problem; Output Problem

  THE USER'S PARENTS REPORTED THAT THE CHILD HEARD VERY WELL UNTIL ONE MONTH AGO ((B)(6) 2020), THEN SHE WAS UNABLE TO HEAR ANYMORE.

  Patient problems: Failure of Implant

  MAUDE report 11018730 ↗

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