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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 07/27/2013
Event Type  Injury  
Event Description

It was reported that the patient was experiencing chest pain and underwent device explant. It was also reported that the patient did not experience efficacy with vns therapy. It was reported that the patient's device was programmed off on (b)(6) 2013. Device diagnostics were within normal limits. It was reported that the patient had complained of chest pain that had been occurring for 3 days. The patient noted significant relief from the chest pain when the device was programmed off. It was also reported that clinic notes dated (b)(6) 2013 noted migration of the device and because of the patient's chest pain the patient was referred for surgery because the neurologist thought there may be an issue with the device. It was noted that the patient was seizure free since the device was programmed off so the patient's family asked for device explant with no plans to reimplant. The explanted generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts to obtain additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key4055314
Report Number1644487-2014-02181
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2010
Device MODEL Number102
Device LOT Number2177
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2014
Event Location Other
Date Manufacturer Received08/06/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/09/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/03/2014 Patient Sequence Number: 1
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