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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 05/01/2012
Event Type  Injury  
Event Description

It was reported through clinic notes dated (b)(6) 2012 that patient was experiencing a new seizure variation tonic posturing then bends forward at waist then back up for the past 3 weeks. The patient's mother indicated that this was the worst seizure type seen in 20 years. Follow-up was made with the treating physician and it was indicated that upon checking function of vns, battery icon showed 25% life remaining. The new seizure was believed to be associated with low battery life. Additionally, increased activity could be related to decrease in output current on (b)(6) 2012 to maximize magnet benefit. At the moment, the patient has been referred to neurosurgery for battery replacement. Diagnostics at the office visit of (b)(6) 2012 indicated ok/2778/ok/no after a decrease in output current. However, diagnostics from the previous office visit ((b)(6) 2012) indicated eos=yes.

 
Event Description

Reporter indicated vns diagnostics for the patient's vns generator were within normal limits on (b)(6) 2012 with 2885 ohms, and the generator was not at end of service. The output current was increased from 1ma to 2ma at that time. The patient's medications were increased in (b)(6) 2012 to allow for greater seizure control, but the reporter felt the seizure increase was due to a depleting vns battery. The patient has also been experiencing behavioral issues since (b)(6) 2012. The patient was referred for generator replacement to preclude a serious injury that may result from either the increased seizures or behavioral issues if no improvement was seen. The patient had generator replacement surgery performed on (b)(6) 2012. The explanted generator has been returned and is pending analysis. Paperwork returned with the generator indicated the replacement was prophylactic.

 
Event Description

All further attempts to the reporter for information have been unsuccessful to date.

 
Event Description

Product analysis was completed on the returned vns generator. The generator was found to be at vbat

 
Event Description

Reporter indicated the patient's seizures had improved since the vns was replaced on (b)(6) 2012, and that the new seizure type has completely resolved since the vns replacement. The new seizure type was described as tonic posturing with bending forward, nostrils sucked in, and mouth clenched. The mother states the patient's seizures have improved since the replacement. The reporter stated vns has helped the patient's behavior as well.

 
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Brand NamePULSE GEN MODEL 103
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2629599
Report Number1644487-2012-01603
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2010
Device MODEL Number103
Device LOT Number200929
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/26/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/18/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2008
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: 06/26/2012 Patient Sequence Number: 1
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