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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Impedance Problem
Event Date 09/02/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that during implant surgery system diagnostics returned high impedance. A system diagnostic test was performed with the resistor connected to the generator with lead impedance value within normal limits. The patient was left with generator and lead connected to the vagus, but generator turned off. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears not to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No lead breaks or sharp angles were found in the parts of the lead that could be assessed. Additional information was received that patient was readmitted for surgery and upon pin reinsertion into the generator block, the value of the lead impedance measured was within the acceptable range.

 
Manufacturer Narrative

Udi# (b)(4). The previously submitted mdr inadvertently lacked the udi number of the suspect device for the event.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
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 Key5100863
Report Number1644487-2015-05867
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 09/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/08/2017
Device MODEL Number106
Device LOT Number4215
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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