Mi1200 SYNCHRONY PIN +COMPRESSED 09397Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09008737093976), received between Jul 2, 2019 and Apr 3, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Circuit Failure; No Device Output; Circuit Failure; No Device Output

  THE USER REPORTS THAT SINCE 2 WEEKS HE HEARS 3 "BEEPS" WHEN HE PUTS ON THE EXTERNAL DEVICE. EVERYTHING ELSE IS WORKING NORMALLY AND HIS HEARING IS NORMAL. IN SITU MEASUREMENTS COULD NOT BE PERFORMED DUE TO INTEGRITY FAILURE. THERE HAVE BEEN NO RECENT CHANGES IN HEALTH OR MEDICATION. ACCORDING TO NEW INFORMATION FROM 26.MAR.2024 THERE WAS SOME LEAKAGE OF THE DEVICE.

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

  MAUDE report 19032533 ↗
• MalfunctionMar 25, 2024Malposition of Device; Malposition of Device

  DURING THE INITIAL SURGICAL PROCEDURE, THE ACTIVE ELECTRODE ARRAY COULDN'T BE FULLY INSERTED INTO THE USER'S COCHLEA DUE TO ANATOMICAL ISSUES. THE CLINIC WAS ONLY ABLE TO INSERT 4 CHANNELS WHICH WAS CONFIRMED BY IMAGING. THE CLINIC NOTICED MULTIPLE CHOLESTEATOMAS AND OTHER EAR DISEASES. THE USER DID NOT FOLLOW THE RECOMMENDED CLINICAL AFTERCARE, RECENTLY PRESENTED AT THE CLINIC FOR EXPLANTATION, HAVING RELIED ON HEARING FROM THE CONTRALATERAL SIDE AND HAVING NEVER EXPERIENCED ANY HEARING PERCEPTION POST-SURGERY WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18966825 ↗
• MalfunctionJan 26, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED AFTER A TRAUMA TO THE HEAD. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18585814 ↗
• InjuryApr 20, 2020Output Problem; Output Problem

  THE USER SUSTAINED A TRAUMA ON THE REGION OF THE IMPLANT. FOLLOWING THE INCIDENT THE USER COULD NO LONGER HEAR WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 9977062 ↗
• InjuryOct 24, 2019Output Problem; Output Problem

  IN (B)(6) 2019, THE RECIPIENT UNDERWENT SURGERY TO REPOSITION THE STIMULATOR HOUSING. DURING THIS PROCEDURE THE ACTIVE ELECTRODE WAS REPORTEDLY NOT MOVED. THIS PROCEDURE WAS CONDUCTED AS THE USER WAS UNABLE TO WEAR THE AUDIO PROCESSOR FOR LONG, DUE TO FEELING PAIN AT THE MAGNET SITE. THE SKIN BECAME THINNER AND AN ULCER FORMED. THE EXTERNAL MAGNET STRENGTH WAS THOUGHT TO BE APPROPRIATE FOR THE USER. SINCE THE REPOSITIONING SURGERY THE RECIPIENT HAS NO AUDITORY SENSATION WITH THE DEVICE. ADDITIONALLY, THE USER REPORTEDLY HAD NO AUDITORY SENSATION WITH THE DEVICE BEFORE REPOSITIONING SURGERY. THE USER HAS BEEN RE-IMPLANTED. ACCORDING TO THE DEVICE EXPLANTATION REPORT, THE ELECTRODE ARRAY WAS OUT OF THE COCHLEA.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 9232822 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  AFTER INITIAL IMPLANTATION, IMAGING SHOWED ELECTRODES PASSING THROUGH THE ROUND WINDOW WITH KINKING AND FOLDING OF THE ELECTRODE ARRAY IN THE FIRST 3 MM OF THE BASAL TURN. ALSO, DURING THE INSERTION, THE ELECTRODE CONTACTS APPEARED TO BE DISCONNECTED FROM THE SILICON. PER THE IMPLANT REGISTRATION CARD, 2 ELECTRODES WERE LEFT EXTRA-COCHLEAR. THE DEVICE WAS NEVER ACTIVATED, AND THE RECIPIENT WAS RE-IMPLANTED 5 DAYS AFTER INITIAL SURGERY.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 8752060 ↗

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-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-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. Mi100