ZINGER GUIDE WIRE - CRDM LVZRXT180S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc.

Event Text Entries

[33546661] This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[33546662] It was reported that during implant a guidewire could not be removed from the patient because portions of the guidewire were stuck on the distal portion of the lead. Another guidewire was attempted and could only be introduced from the proximal to the distal end of the lead. The lead and guidewires were not used, another lead was successfully implanted with another guidewire. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[47402399] Product event summary: the guidewire was returned, analyzed, and the guidewire was broken. It was noted that the guidewire was unraveled. As received the wire was badly damaged, stretched, and broken, and was missing approximately 2. 5 cm from the distal bond joint to the distal tip. The damage is consistent with damage incurred during destructive analysis.
Patient Sequence No: 1, Text Type: N, H10


[101875099] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220452-2015-00060
MDR Report Key5280171
Date Received2015-12-09
Date of Report2015-09-15
Date of Event2015-09-15
Date Mfgr Received2016-03-16
Device Manufacturer Date2014-12-30
Date Added to Maude2015-12-09
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 FDA3
Event Location3
Manufacturer ContactANNE SCHILLING
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635052036
Manufacturer G1MEDTRONIC CARDIAC RHYTHM HEART FAILURE
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZINGER GUIDE WIRE - CRDM
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2015-12-09
Returned To Mfg2015-10-01
Model NumberLVZRXT180S
Catalog NumberLVZRXT180S
Lot NumberG14A08936
Device Expiration Date2017-12-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC
Manufacturer Address37A CHERRY HILL DR DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-09

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