MalfunctionNVP
HOLDING CHAMBERS, DIRECT PATIENT INTERFACE
Received Aug 12, 2023
Report MW5133321 · MDR key 17526382
Device
Generic name
Holding Chambers, Direct Patient Interface
Manufacturer
BiotronikModel number
UNKNOWN PACERProduct problems
- Computer Software Problem
- Computer Software Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S BIOTRONIX PACES WASN'T FUNCTIONING AS EXPECTED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).