SONNET 2 EAS CPU Me1520 beige 34953Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09008737349530), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE USER WAS IMPLANTED ON (B)(6)2022 ON THE LEFT EAR, AND WAS ACTIVATED AND WAS USING HER EXTERNAL DEVICE WITHOUT ANY PROBLEM UNTIL THE SURGERY OF THE CONTRA LATERAL RIGHT EAR ON 08-MAR-2023. AFTER THIS SURGERY, THE CHILD DID NOT WANT TO WEAR THE EXTERNAL DEVICE ANYMORE AND COMPLAINED ABOUT PAIN WHEN USING IT, THROWING IT AWAY EVERY TIME THE PARENTS WANTED TO PUT IT ON HER LEFT EAR. ONLY BIPOLAR CAUTERY WAS USED AT IMPLANTATION OF THE CONTRA-LATERAL DEVICE. MAPPING CAN BE RULED OUT AS AN ISSUE SINCE THE USER DOES NOT EVEN TOLERATE STIMULATION LEVELS LOWER THAN THOSE OF ACTIVATION. THE USER WAS GIVEN A NEW AP TO TRY AT HOME. AS OF (B)(6)2023 IT WAS REPORTED THAT THE USER IS USING THE LOANER AP WITHOUT ANY ISSUE STILL. THE AP WHICH CAUSED THE REPORTED SYMPTOMS WILL BE RETURNED ONCE A NEW AP FOR THE USER ARRIVES.

  Patient problems: Discomfort

  MAUDE report 16782711 ↗

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