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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

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CYBERONICS INC BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2015
Event Type  malfunction  
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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Brand Name
BIPOL LEAD MODEL 300
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key4532068
MDR Text Key5355004
Report Number1644487-2015-03919
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 01/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2000
Device Model Number300-20
Device Lot Number9623C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 01/26/2015
Initial Date FDA Received02/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/1998
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age36 YR
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