ZINGER MEDIUM LVZRMS180S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for ZINGER MEDIUM LVZRMS180S manufactured by Medtronic, Inc.

Event Text Entries

[42757033] 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


[42757034] It was reported that the guide wire during implant unraveled and it was difficult to move the guide wire into the lumen of the lead. The guide wire was replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[101876323] 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 Number1220452-2016-00021
MDR Report Key5560101
Date Received2016-04-07
Date of Report2016-01-26
Date of Event2016-01-26
Date Mfgr Received2016-01-26
Device Manufacturer Date2015-02-03
Date Added to Maude2016-04-07
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, INC
Manufacturer Street37A CHERRY HILL DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal Code01923
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameZINGER MEDIUM
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2016-04-07
Model NumberLVZRMS180S
Catalog NumberLVZRMS180S
Lot NumberG15A01783
Device Expiration Date2018-02-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC
Manufacturer Address37A CHERRY HILL DR DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-07

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