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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300
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CYBERONICS - HOUSTON LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Corroded (1131)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's lead was explanted and returned for analysis.The lead was returned in one section.There were set screw marks on the connector pin which showed that at one point in time proper contact existed.There was pitting (corrosion) noted in the vicinity of the set screw marks.
 
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Brand Name
LEAD MODEL 300
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key8126535
MDR Text Key129155462
Report Number1644487-2018-02195
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 company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2018
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 Date07/31/2001
Device Model Number300-20
Device Lot Number25358C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2018
Event Location Other
Initial Date Manufacturer Received 11/08/2018
Initial Date FDA Received12/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/1999
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 Age68 YR
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