MalfunctionDRG
CONFIRM¿ MOBILE TRANSMITTER/ACTIVATOR PATIENT SMARTPHONE
Received Aug 9, 2024 · Event occurred Jul 22, 2024
Report 2017865-2024-62239 · MDR key 19956095
Device
Generic name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
MTX1000Catalog number
MTX1000
Lot number
ABTUS1032
Product problems
- Computer System Security Problem
- Computer System Security Problem
Patient
51 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY PATIENT THAT THE TRANSMITTER WAS HACKED AND A SCREENLOCK PASSCODE WAS ENABLED. THE TRANSMITTER WAS EXCHANGED. THERE WERE NO PATIENT CONSEQUENCES.