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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 04/30/2014
Event Type  Injury  
Event Description

Initially, tt was reported that the patient is feeling a throbbing in the area of the left where the lead is when she turns her head to the right. The patient denied any trauma to the area. It was reported that device diagnostics were within normal limits (dc dc code - 1). It was later reported that the patient experiences a tingling sensation in the left neck when the patient turns her head to the right. The magnet was placed over the device to temporarily disable stimulation and the tingling went away. X-rays were taken and reportedly "looked good". It was later reported that the patient's mother wants the patient to undergo vns replacement. The patient was referred to surgeon for consult. No surgical interventions have been performed to date.

 
Event Description

It was reported that the patient underwent generator and lead replacement on (b)(6) 2015. Pre-operative device diagnostics were within normal limits. The surgeon indicated that there were two small water bubbles in the lead when the neck incision was opened. There was condensation in the generator header where the lead was attached to the generator. Both generator and lead were replaced. The device was confirmed to be programmed off prior to the completion of surgery. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/09/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.

 
Event Description

Additional information was received from the patient¿s treating physician. The believed cause for the patient's report of pain on the left side of the neck when she turns her head to the right has never been clear. The unit has been interrogated numerous times with the patient in different positions, and the unit appeared to be functioning correctly at all times per the interrogation. She has not experienced any pain during any of the times she was having the unit interrogated. The patient¿s surgery was done to relieve discomfort. She continued to complain of twitching sensations. She and her family were also concerned because the vns did not seem to be functioning as it once had. They consistently reported that when the magnet was swiped across the vns unit, it no longer seemed to have any impact on the seizure and she just had to go through the full seizure. The settings prior to surgery were: output current-1. 25 ma, and magnet output current-3. 25 ma analysis of the explanted lead was completed on 02/17/2015. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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 Key4341794
Report Number1644487-2014-03395
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 12/02/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/1999
Device MODEL Number300-20
Device LOT Number4593C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/1997
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: 12/18/2014 Patient Sequence Number: 1
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