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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/01/2012
Event Type  Malfunction  
Event Description

It was initially reported that the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. The generator would not communicate in the product analysis lab. The battery was found to be depleted, 1. 532 volts as measured with the can removed and battery still attached to the pcb. Post burn-in electrical test results showed that the pulse generator pcb module performed according to functional specifications except for the c4 out of specification condition. The cause for the out of specification c4 capacitor (v cpu) value is likely associated with component aging. A review of pre-temp and post-burn automated electrical test results (performed during manufacture of the product) revealed that a communication error (e. G. Test results display "9999") prevented the correct value from being programmed into the programmed into the device during both electrical tests which resulted in the parameter's current state. No other issues were identified with the returned generator. During electrical testing of a generator's (model 103-106) printed circuit board (pcb), the generator is calibrated to measure voltage using a two point curve from which the trim values diagvbatb and diagvbatm are assigned as the gain and offset of this calibration curve. Diagvbateos threshold corresponds to the threshold level at which the generator will disable output as an eos response and is set at manufacturing after the establishment of diagvbatm and diagvbatb.

 
Manufacturer Narrative

A communication error prevented the correct value from being programmed into the device during both electrical tests which resulted in the pulse not disabled.

 
Event Description

Clinic notes were received providing that the patient can tell when the battery gets low due to changes in behavior and speech but it has little effect on seizures; they are perhaps less intense.

 
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Brand NamePULSE GEN MODEL 103
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 Key2916322
Report Number1644487-2013-00160
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE,HEA
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL Number103
Device LOT Number1894
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2012
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/16/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/02/2007
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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