ZINGER LIGHT LVZRLS180S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2013-08-09 for ZINGER LIGHT LVZRLS180S manufactured by Rice Creek Mfg.

Event Text Entries

[15778131] It was reported that during the implant procedure, the guidewire could not be retracted. On fluoroscopy, the image shows a "curled tip" of the guidewire. The guidewire was suspected to be fractured at the tip. The physician was unable to put traction force on it without risking the guidewire to break off at the tip and leave part in the heart. The physician was also unable to reposition the left ventricular (lv) lead at this point without damage. It was tried to remove lead and guidewire as a unit, but this was not possible as a small distal part of the wire remained stuck in the venous structure while part of the wire remained attached as well to the distal part of the lead. It was then decided by the physician to leave both guidewire and lv lead implanted in the patient. Patient is part of the (b)(6) study. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[15872747] 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


MAUDE Entry Details

Report Number2182208-2013-02042
MDR Report Key3275130
Report Source01,02,05,07
Date Received2013-08-09
Date of Report2013-05-06
Date of Event2013-05-06
Date Mfgr Received2013-05-06
Date Added to Maude2013-11-05
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 Location0
Manufacturer ContactNASHOANE FULWOOD-KELLEY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635260583
Manufacturer G1MEDTRONIC CARDIAC RHYTHM DISEASE MGMT
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 LIGHT
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2013-08-09
Model NumberLVZRLS180S
Catalog NumberLVZRLS180S
Lot Number60293
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRICE CREEK MFG
Manufacturer Address7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432


Patients

Patient NumberTreatmentOutcomeDate
10 2013-08-09

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