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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 05/09/2017
Event Type  Malfunction  
Event Description

It was reported that a lead could not be fully inserted into a generator, causing high impedance to occur during implant surgery. The surgeon tried removing and reinserting the lead multiple times, but the high impedance continued to occur. The lead could not be implanted due to the high impedance/insertion difficulties. The generator was tested with a test resistor and confirmed that it was accurately measuring impedance values. A different lead was implanted and post-op impedance values were all within normal limits. The lead that was not implanted has not been received by the manufacturer to date.

 
Event Description

The lead that was unable to be inserted was returned to the manufacturer for analysis. The visual analysis of the lead found the small o-ring appeared partially detached from the connector pin. Dimensional analysis was performed on the small o-ring, the large o-ring, the connector pin, and the connector boot and provided results all within normal limits. A half set of screw marks was identified on the lead pin confirming that the lead had not been fully inserted during implant. Continuity checks of the returned lead assembly verified that there were no discontinuities present. The remainder of the lead was within specifications and no other abnormal performance or other adverse conditions were identified.

 
Event Description

An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of 0. 135 in max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. This lead had both characteristics. The lead's large o-ring boot diameter was 0. 134 in, which is close to the 0. 135 inches specification max and therefore, may cause pin insertion difficulties. In addition, review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
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 Key6604102
Report Number1644487-2017-03902
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number303-20
Device LOT Number300347
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/21/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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