inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY

Received Jun 21, 2024

Report 3004824012-2024-00018 · MDR key 19584804

Device

Generic name

Transcranial Magnetic Stimulator

Manufacturer

Neuronetics, Inc.

Catalog number

81-02315-000

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

49 YR · Male

  • Retinal Tear
  • Retinal Tear

Narrative

Additional Manufacturer Narrative

NEURONETICS RECEIVED A REPORT FROM A PROVIDER THAT A PATIENT DEVELOPED A RETINAL TEAR IN THEIR LEFT EYE AFTER RECEIVING 13 TREATMENTS. PATIENT REPORTEDLY DOES NOT HAVE A HISTORY OF RETINAL DISEASE. NEURONETICS HAS ATTEMPTED TO OBTAIN MORE INFORMATION ON THE PATIENT AND COMPLAINT BUT HAS BEEN UNSUCCESSFUL.

Description of Event or Problem

NEURONETICS RECEIVED A REPORT FROM A PROVIDER REGARDING A PATIENT WHO DEVELOPED A RETINAL TEAR IN HIS LEFT EYE AFTER RECEIVING 13 TREATMENTS.