FDA.reportPublic FDA data

MAUDE MDR 2291016

MDR report key
2291016
Report number
2182208-2011-02211
Event key
0
Event type
3
Date received
2011-10-13
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
CHAD HEDLUND SR VIGILANCE COMPLIANCE MGR
Address
CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. 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
1NONELEAD SERVICE KITMEDTRONIC, INC.KFJ5873WASKUASKUN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-1369491. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ATTEMPTING TO PLACE THE LEAD INTO THE COMPETITOR DEVICE FIVE WRENCHES BROKE WHILE TIGHTENING AND UNTIGHTENING THE SETSCREW. IT WAS NOTED THAT THE METAL CAME OUT OF THE WRENCHES. IT WAS ALSO REPORTED THAT THE LEAD HAD INCREASING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

N

Patient 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.