NONE 5873W

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-10-13 for NONE 5873W manufactured by Medtronic, Inc..

Event Text Entries

[18509061] 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.
Patient Sequence No: 1, Text Type: D, B5


[18740109] The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2182208-2011-02213
MDR Report Key2291023
Report Source05,07
Date Received2011-10-13
Date Mfgr Received2011-07-29
Device Manufacturer Date2011-05-05
Date Added to Maude2011-10-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactCHAD HEDLUND SR VIGILANCE COMPLIANCE MGR
Manufacturer StreetCARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E.
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635149619
Single Use3
Previous Use Code3
Removal Correction NumberASKU
Event Type3
Type of Report3

Device Details

Brand NameNONE
Generic NameLEAD SERVICE KIT
Product CodeKFJ
Date Received2011-10-13
Model Number5873W
Catalog NumberASKU
Lot NumberASKU
ID NumberASKU
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer AddressCARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
169491. Other 2011-10-13

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