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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 03/01/2014
Event Type  Injury  
Event Description

Additional information was received stating that the vns patient had a big aura on (b)(6) 2014. The patient became light-headed and was diaphoretic. The patient swiped her magnet but it did not help her aura. The patient stated that her previous auras were similar but not back up to pre-vns baseline levels. The patient did not have any auras after (b)(6) 2014. The patient also reported that her vns stimulation was no longer as strong as it was in the past. The patient¿s pre-operative evaluations had been completed. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the patient underwent prophylactic generator replacement. It was reported that preoperative and postoperative device diagnostics were within normal limits (dc dc code - 2). It was reported that the patient has not yet been seen for follow-up with the neurologist since the surgery. It was reported that the explanting facility discarded the explanted generator; therefore analysis cannot be performed.

 
Event Description

It was reported that the vns patient was experiencing an increase in seizures and pain/tightening at her lead site for the month prior to her office visit on (b)(6) 2014. The patient¿s device was not at end of service and had normal lead impedance (dc dc 2). The neurologist stated that the generator battery was probably low and was causing the patient¿s issues. Until recently, the patient was seizure free since vns. The patient also recently began experiencing daily auras. The patient had a bump on her neck that appeared a month before the office visit. The neurologist stated that the lead may no longer be tied down. The patient did not experience any pain when the lead site was touched but intermittently when vns stimulation occurred. X-rays were taken but have not been provided to the manufacturer for further evaluation. The patient was referred for generator replacement surgery. No known surgical interventions have occurred to date. Clinic notes were received indicating that the patient¿s device had not been interrogated for the past ten years. The patient reported having a tingling feeling at the generator site and can still feel stimulation that sometimes caused her to have voice hoarseness. As the patient¿s auras were becoming more frequent, the patient¿s settings were increased. Review of the available programming and diagnostic history showed the last known device settings were from 04/11/2003.

 
Manufacturer Narrative

Review of the available programming and diagnostic history.

 
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Brand NamePULSE GEN MODEL 101
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 Key3804675
Report Number1644487-2014-01239
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 04/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2003
Device MODEL Number101
Device LOT Number5692
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/23/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2002
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: 05/12/2014 Patient Sequence Number: 1
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