FDA.reportPublic FDA data

MAUDE MDR 9908949

MDR report key
9908949
Report number
1627487-2020-03477
Event key
0
Event type
3
Date of event
2020-03-12
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANDREA DEITZ
Address
6901 PRESTON ROAD PLANO TX 75024 US
Phone
972-972-9723
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATORSCS IPGST. JUDE MEDICAL - NEUROMODULATIONLGW366236625765846R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

DATE OF EVENT IS ESTIMATED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INACCURATE ELECTIVE REPLACEMENT INDICATOR ADVISORY NOTICE ISSUED BY ABBOTT ON 12 SEPTEMBER 2017.

D

Patient 1

IT WAS REPORTED THE PATIENT?S CONTROLLER DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. TROUBLESHOOTING WAS PERFORMED IN WHICH THE APP WAS UPDATED, CLEARING THE MESSAGE AND RESOLVING THE ISSUE.