FDA.reportPublic FDA data

MAUDE MDR 9898321

MDR report key
9898321
Report number
2182208-2020-00615
Event key
0
Event type
3
Date of event
2020-02-13
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARELINK PROGRAMMERPROGRAMMER, PACEMAKERMEDTRONIC, INC.KRG2090WDE2090WDEY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-300

Event Narratives#

N

Patient 1

PRODUCT ANALYSIS: ANALYSIS DETERMINED THAT THE STYLUS PEN WAS WORN OUT AND FALTERED IN THE LOWER RIGHT CORNER OF THE DISPLAY SCREEN. IT WAS NOTED THAT THERE WAS A SOFTWARE ERROR CODE AND THAT SOFTWARE PERFORMANCE WAS SLOW WHEN ANOTHER APPLICATION WAS STARTED. NEW SOFTWARE WAS INSTALLED AND UPDATED TO THE NEWEST VERSION. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE THEN PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT THE PROGRAMMER REQUIRED UNSPECIFIED REPAIRS. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER STYLUS PEN SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.