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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 07/22/2014
Event Type  Malfunction  
Event Description

It was reported that the recently implanted vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value - 7503 ohms). The patient¿s device was tested a second time and the device continued to show high impedance. The neurologist had the patient¿s device programmed on during the office visit. Diagnostic results from the implant procedure showed lead impedance within normal limits. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin does not appear fully inserted into the generator connector block. The electrodes appear to be aligned at a steep angle away from the nerve, nearly perpendicular to the nerve. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance is likely due to incomplete lead pin insertion. The patient experienced a seizure cluster so she swiped her magnet. Immediately, she began feeling intense chest pain and went to the er. The patient was hospitalized overnight. No known surgical interventions have occurred to date.

 
Event Description

Follow-up revealed that the patient was experiencing a ¿pinching¿ sensation across her chest and down her left side during stimulation on-times. The patient¿s device frequency and pulse width were decreased from 30hz to 20hz and from 500usec to 250usec, respectively. The patient¿s symptoms subsequently improved. The patient reportedly continued to have pain in her chest, but the physician indicated that the pain was not related to vns.

 
Manufacturer Narrative

Corrected data: the initial manufacturer report inadvertently did not include that the patient device had been disabled.

 
Event Description

Follow-up revealed that the patient铠device was disabled. Additional information was received indicating that the vns patient's medications were increased and the patient had gone to the er on two occasions to received iv anti-epileptic medications. The patient's seizure frequency was back to pre-vns baseline levels (2-3 small seizures per week). The patient's seizure cluster is not believed to be due to vns. Prior to the seizure cluster, the patient was given a new medication. After the seizure cluster, the patient was taken off the medication but it is unknown if this medication was the source of the seizure cluster. It was noted that the patient had poor seizure control prior to implant surgery. The patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostic results showed high impedance (impedance value - 7076 ohms). The surgeon noted that the lead pin was not fully inserted into the generator header. The patient's lead pin was reinserted and multiple diagnostic results showed lead impedance within normal limits.

 
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Brand NamePULSE GEN MODEL 105
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 Key4013657
Report Number1644487-2014-02042
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2016
Device MODEL Number105
Device LOT Number202846
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/05/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/27/2014
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: 08/15/2014 Patient Sequence Number: 1
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