FDA.reportPublic FDA data

MAUDE MDR 2606223

MDR report key
2606223
Report number
2182208-2012-01873
Event key
0
Event type
3
Date of event
2012-03-02
Date received
2012-06-08
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
1IMPLANTABLE PULSE GENERATOR ACCESSORYMEDTRONIC, INC.DTFWRENCHY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-0840761. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE ATRIAL LEAD WAS CHALLENGING TO ENGAGE THE SET SCREW AND THE DRIVER DISLODGED TWICE. IT WAS ALSO REPORTED THAT THE SET SCREW WAS UNABLE TO BE RE-ENGAGED. A NEW WRENCH WAS USED WITHOUT DIFFICULTY AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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. EVALUATION SUMMARY: WRENCH THE WRENCH WAS RETURNED, ANALYZED, AND ANALYSIS FOUND NO ANOMALIES. BY USING A SAMPLE DEVICE THE WRENCH WAS ABLE TO TIGHTEN AND LOOSEN SETSCREWS WITH NO ANOMALIES FOUND.