Definitions
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
What is a complaint?
GIB with blood transfusion. One month later, patient presents with GIB again.
Merge/Append
Investigation is completed
What is Reassess General?
HRM4602, ADV181
What are PSC Codes?
Code that describes the allegation against the device, found in the reportability matrix
What is the RFR code?
A battery is reported for a critical battery alarm. Two weeks later the battery is reported for not charging.
Follow-up mPXR is sent in after event has been promoted.
What is General-Interface?
Results pending completion of investigation
What is a Result Code (FDR)?
Partner describing the Medtronic employee who conveys allegations to the complaint handling unit
A controller is reported for loss of power. Two days later, new information comes in that a battery has been involved in power disconnects resulting in the controller losing power
Merge/Append
What are Geo Interface and General Interface tasks?
Thrombus, Hemolysis
What is a Patient Code (FDP)?
The process that includes but is not limited to returned devices, media, data, and software logs.
What is the Product Analysis?
Power switching with lubrication. One month later, lubricated batteries switch again
New SR
Product analysis is completed on a non-reportable event. A primary AFC has been assigned to the PLI
What is an RD reassess task?
VA24GW
The attempt to obtain additional information regarding the event or return status of devices
Patient had a thrombus. Two days later, patient had an embolic stroke associated with the thrombus
Merge/Append
Additional information has been received and attached by another specialist.
What is Reassess General?