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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 06/05/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013 indicated that this vns patient¿s seizures have been fairly stable, but the patient¿s parents wondered if the patient was depressed. The patient slept for 15-16 hours per day and did not seem to be interested in doing things that he was interested in doing before. The caregivers wondered if the vns was working. The device was interrogated and was still doing well, per the physician. The physician indicated that it was possible that if the vns was not functioning right, it could allow some more depression symptoms to occur. Attempts for additional information have been unsuccessful. The patient has been referred for prophylactic revision. Surgery is likely but has not taken place.

 
Event Description

On (b)(6) 2013, it was reported that the explanted generator was discarded.

 
Event Description

It was reported that the generator was not discarded and will be returned to manufacturer for analysis. The generator was received on (b)(4) 2013. The generator analysis was completed on (b)(4) 2013. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

 
Manufacturer Narrative

 
Event Description

On (b)(6) 2013 it was reported that the patient underwent generator replacement that day. System diagnostics were noted to be performed without error. The explanted generator has not been returned for product analysis 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 770
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 Key3223737
Report Number1644487-2013-02089
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2009
Device MODEL Number102
Device LOT Number017112
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/24/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2007
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: 07/12/2013 Patient Sequence Number: 1
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