TRANSMITTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-29 for TRANSMITTER manufactured by Cdi Medical Services.

Event Text Entries

[10440] Pt has pacemaker which is regularly tested via transmitter. On 3/17/94 pt was unable to transmit for testing. Mfr contacted via toll free number and said to mail non-functioning transmitter and they would send rptr new product. Pacemaker is still functioning correctly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1001313
MDR Report Key12385
Date Received1994-03-29
Date of Report1994-03-18
Date of Event1994-03-17
Date Added to Maude1994-03-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRANSMITTER
Product CodeDXH
Date Received1994-03-29
Returned To Mfg1994-03-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key12385
ManufacturerCDI MEDICAL SERVICES
Manufacturer AddressWINDSOR CT 06095 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.