Mi1000 MED-EL CONCERT PIN +FLEX28 08362Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 09008737083625), received between Jul 3, 2018 and Apr 24, 2026 — classified as 26 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Output Problem” (36 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978587 ↗
• MalfunctionJul 28, 2025Impedance Problem; Impedance Problem

  REPORTEDLY, THE USER SHOWED CHANGES IN IMPEDANCE TESTS SINCE 2023. HOWEVER, THE FAMILY DOES NOT REPORT CHANGES IN AUDITORY BEHAVIORS THAT YEAR. AN INTERGRITY TEST HAS BEEN REQUESTED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629277 ↗
• MalfunctionMay 20, 2025Circuit Failure; Impedance Problem; Circuit Failure; Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050125 ↗
• MalfunctionMar 21, 2025Impedance Problem; Impedance Problem

  THE USER HIT THE LEFT SIDE OF THER HEAD IN A SOCCER GOAL. SHE CAN NOT HEAR ANYTHING WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Head Injury

  MAUDE report 21661228 ↗
• MalfunctionJul 29, 2024Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER NOTICED THAT THE SOUND IS QUIETER.

  Patient problems: Failure of Implant

  MAUDE report 19849270 ↗
• MalfunctionApr 26, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER'S PARENTS NOTICED THAT THE CHILD DID NOT HEAR WHEN THE RIGHT EAR PROCESSOR WENT OFF AND WENT TO THE CLINIC FOR TROUBLESHOOTING. REIMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 19189854 ↗
• MalfunctionOct 2, 2023Impedance Problem; Impedance Problem

  THE USER ATTENDED THE SERVICE FOR ROUTINE MAPPING, AND A DECREASE IN AUDITORY PERFORMANCE WAS FOUND.

  Patient problems: Failure of Implant

  MAUDE report 17850170 ↗
• MalfunctionAug 4, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER CONTACTED AUDIOLOGY TECHNICAL SUPPORT AFTER HAVING A CONTRAINDICATED MRI DONE ON (B)(6) 2023. SHE DENIED PAIN OR DISCOMFORT DURING THE MRI BUT WHEN SHE GOT HOME, SHE REPORTED THE PROCESSOR MAGNET REPELLED FROM THE INTERNAL MAGNET. WHEN SHE TRIED TO WEAR IT, SHE EXPERIENCED AN ABNORMAL SOUND QUALITY AND SENSATION. THE USER SENT MED-EL THE MRI REPORT THAT SHOWED THAT A 3.0 T MRI WAS PERFORMED AND THERE WAS NO HEAD-WRAP. THE USER HAS DECIDED TO GO AHEAD WITH REVISION SURGERY, IT IS LIKELY TO TAKE PLACE IN (B)(6) 2023.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17457175 ↗
• MalfunctionApr 21, 2023Impedance Problem; Impedance Problem

  IN-SITU MEASUREMENTS SHOW AFFECTED CHANNELS. REPORTEDLY THE HEARING PERFORMANCE WITH THE DEVICE IS ALSO AFFECTED.

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

  MAUDE report 16783206 ↗
• MalfunctionNov 22, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER SUFFERED A FALL IN (B)(6) 2022. FURTHERMORE, AFFECTED CHANNELS WERE SEEN. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 15841867 ↗
• MalfunctionOct 19, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER REFERS A GRADUAL DECREASE IN AUDITORY PERFORMANCE WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15630636 ↗
• MalfunctionSep 29, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER FELL AND HIT THE HEAD AND CONSEQUENTLY COULD NOT HEAR ANYMORE.

  Patient problems: Failure of Implant

  MAUDE report 15507831 ↗
• MalfunctionSep 6, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER'S FAMILY PERCEIVED IN APRIL 2022 THAT THE USER WAS NOT PRESENTING AUDITORY PERCEPTION WITH THE DEVICE. NO TRAUMA HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15362781 ↗
• MalfunctionMay 31, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER'S MOTHER HAD NOTICE THAT THE CHILD IS NOT HEARING WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 14546755 ↗
• MalfunctionApr 21, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  PER INFORMATION RECEIVED FROM THE SURGEON, THE USER INSERTED A COTTON SWAB INTO THEIR EAR CAUSING EXTRUSION OF THE ELECTRODE ARRAY. THE USER WAS RE-IMPLANTED, ACHIEVING A COMPLETE INSERTION WITH THE NEW DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 14165522 ↗
• MalfunctionFeb 7, 2022Output Problem; Output Problem

  TWO MONTHS PRIOR THE RECIPIENT REPORTED THAT HER RIGHT IMPLANT STARTED BUZZING AND CAUSING PAIN. WHEN ASKED SPECIFICS, SHE POINTED TO THE MIDDLE OF HER COIL AS THE SOURCE OF THE PAIN. THE RECIPIENT STOPPED WEARING HER RIGHT AUDIO PROCESSOR AT THAT TIME. EXTERNAL EQUIPMENT WAS REPLACED WITH NO IMPROVEMENT. THE RECIPIENT WAS REIMPLANTED AND IS DOING WELL WITH HER NEW DEVICE. SHE DID NOT NOTE ANY PAIN AT THIS TIME.

  Patient problems: Implant Pain

  MAUDE report 13470728 ↗
• MalfunctionOct 18, 2021Output Problem; Output Problem

  THE USER REPORTED THAT SHE SUDDENLY STOPPED HEARING USING THE DEVICE ON (B)(6), 2021. RE-IMPLANTATION WILL BE SCHEDULED WHEN THERE THE NEW DEVICE WILL BE RECEIVED. HOWEVER, NO DATE HAS BEEN PROVIDED YET.

  Patient problems: Failure of Implant

  MAUDE report 12645992 ↗
• MalfunctionOct 15, 2021Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER CAME FOR A FOLLOW-UP FITTING AND THE PARENTS REPORTED THAT THE CHILD IS NOT REACTING TO SOUNDS. THE CHILD DIDN'T REACT RELIABLY SINCE ACTIVATION; THEREFORE, IT IS NOT CLEAR IF SHE EVER HAD ANY BENEFIT FROM THE DEVICE. THE PARENTS REPORTED SHE REACTED TO VOICE OF HER BROTHER IN THE BEGINNING, BUT THEY COULDN'T REPLICATE IT. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 12637997 ↗
• MalfunctionSep 22, 2021Circuit Failure; Output Problem; Circuit Failure; Output Problem

  ON AUGUST 28, THE USER SUDDENLY HEARD A LOUD SOUND COMPARABLE OF A DRILL. SHE HAD TO TAKE OFF THE SPEECH PROCESSOR AS IT WAS VERY LOUD. SHE WAS ABLE TO PUT IT BACK THE FOLLOWING DAY BUT AGAIN AFTER A WHILE SHE HEARD THE SAME NOISE AGAIN. SINCE THEN, SHE HAD CONSTANTLY HEARED THAT NOISE AND THEREFORE WAS UNABLE TO PUT THE PROCESSOR ON.THE USER WAS REIMPLANTED WITH A NEW DEIVCE ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12512057 ↗
• InjuryJul 20, 2021Migration; Migration

  THE RECIPIENT WAS RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2021. A DECLINE IN PERFORMANCE WAS NOTED AROUND THAT TIME.

  Patient problems: Failure of Implant

  MAUDE report 12195482 ↗
• MalfunctionJun 10, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  FOLLOWING MRI THE AREA AROUND THE IMPLANT WAS SORE LIKE A LOW BURN AND THERE WAS A STEADY HUMMING, LIKE TINNITUS. SHE ALSO JUST DID NOT SEEM TO _HEAR_ ANYMORE. IT WAS MORE LIKE SHE WAS AWARE OF SOUNDS. THERE WAS ALSO AN ODD ZAPPING, LIKE A MISFIRING SOUND. NOT AN ACTUAL PHYSICAL SENSATION JUST THE SOUND. ALSO, SINCE THE MRI SCAN THE RECIPIENT PERCEIVED A BURNING AND A SPREADING HEADACHE WITHIN A FEW MINUTES WHEN PLACING THE AUDIO PROCESSOR ON THE HEAD. NO PAIN WAS REPORTED WHEN THE AUDIO PROCESSOR WAS NOT ON. AT EXAMINATION ON JUNE 11, 2021 THE RECIPIENT REPORTED A BURNING SENSATION ON INTERNAL DEVICE AFTER WEARING THE TELEMETRY COIL FOR APPROXIMATELY 10-15 MINUTES AND THE EXAMINER WAS ABLE TO PALPATE A WARMER SPOT NEAR APPROXIMATE LOCATION OF INTERNAL DEVICE AFTER THE TELEMETRY COIL WAS REMOVED. NO OBVIOUS BRUISING OPENED SKIN OR BURNING ON SKIN AROUND THE IMPLANT WERE OBSERVED. ADDITIONALLY, THE RECIPIENT WAS CONCERNED THAT THE INTERNAL DEVICE HAD SHIFTED POSITION IN HER HEAD AND WAS CONTACTING THE METAL PLATE IN HER SKULL FROM PREVIOUS CRANIOTOMY DUE TO BRAIN TUMOR REMOVAL. THE EXTERNAL EQUIPMENT HAS BEEN REPLACED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11973964 ↗
• MalfunctionFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  THE CHILD FELL ON THE STAIRS AND HIT HIS HEAD ON THE IRON RAILING OF THE STAIRS.

  Patient problems: Head Injury

  MAUDE report 11300283 ↗
• InjuryJan 26, 2021Output Problem; Output Problem

  IN (B)(6) 2020 A SUDDEN INCREASE IN THE IMPEDANCE VALUE OF THE GROUND ELECTRODE WAS NOTED. REPORTEDLY, THIS IS THE THIRD TIME THAT THIS WAS OBSERVED AND PREVIOUSLY THE PROBLEM WAS SOLVED USING A HEADBAND. HOWEVER, THAT TIME, DESPITE THE PROLONGED USAGE OF THE HEADBAND, THE ISSUE COULD NOT BE SOLVED. USER WAS REIMPLANTED WITH A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 11228468 ↗
• InjuryAug 31, 2020Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED AFTER A HEAD TRAUMA OCCURRED ON (B)(6) 2020.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 10470279 ↗
• MalfunctionAug 26, 2020Impedance Problem; Output Problem; Impedance Problem; Output Problem

  IT WAS REPORTED THAT THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. NO INCIDENT OF TRAUMA REPORTED.

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

  MAUDE report 10452645 ↗

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-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
• 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