Otomag™ Alpha 2 Sound Processor S0415-02Recalls & reported problems
Medtronic Xomed, Inc. · PROCESSOR S0415-02 ALPHA2MPO AN MRI COND · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169644588), received between Nov 3, 2017 and Nov 3, 2017 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Erosion1
- Erythema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN REPORTED THAT APPROXIMATELY 3 MONTHS POST-IMPLANTATION OF THE SOPHONO DEVICE, THE PATIENT PRESENTED WITH "ERYTHEMA ON MAGNET SITE; INCISION RED AND IRRITATED AND SPONTANEOUSLY BLEEDING." THE SITE WAS TREATED WITH AUGMENTIN, AND THE ISSUE RESOLVED WITHIN 1 MONTH; (B)(6) 2016. PER THE INVESTIGATOR, THE RELATEDNESS OF THIS EVENT TO THE PROCEDURE AND THE SOPHONO SYSTEM IS ¿POSSIBLE¿.
Patient problems: Bacterial Infection; Erosion; Erythema
MAUDE report 6999058 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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