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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 10/20/2011
Event Type  Injury  
Event Description

Additional information was received on (b)(4), 2012 when product analysis was completed on the generator. The device performed according to functional specifications. No elective replacement indicator (eri) flags were observed during testing. The device was continuously monitored for 25. 25 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. On (b)(6) 2012 product analysis on the lead was completed. A portion of the lead assembly body, including the unmarked connector pin section, marked connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity testing could not be performed during the decontamination procedure because the connector pin sections of the returned portion were not returned. Continuity checks of the returned lead portion 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 portion of the device.

 
Event Description

Additional information was received on (b)(6), 2012 when it was discovered that the vns patient was having a full revision surgery that day due to prophylactic reasons. The patient's settings after surgery were going to be output=1. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(4) 2012 that has not yet been completed.

 
Event Description

On (b)(6) 2011 a vns treating physician reported that he is referring the patient for a prophylactic full revision surgery since he is unable to increase the patient's settings to a 130usec pulse width without her having adverse issues. The patient's device is showing elective replacement indicator=no but the patient is having an increase in seizures. A system diagnostics test performed on (b)(6) 2011 showed output=ok/lead impedance=ok/dcdc=2/eri=no and a normal mode diagnostics test showed output=ok/lead impedance=ok/dcdc=2/eri=no. It was reported that on (b)(6) 2011, when normal mode diagnostics were performed, the patient grabbed her throat, gasped for air, and made an odd coughing noise. A system diagnostics had previously been performed with no adverse events and the results showed an output=ok/lead impedance=ok/dcdc=1/eri=no. The patient's settings were output=1. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The patient's mother reported that some weeks the patient will not have a single seizure and then others she will have a couple of seizures. The physician lowered the patient's pulse width but reported that the patient is more than likely faking the events as she has a past history of falsifying events. A battery life calculation was performed with the patient's programming history and it showed negative years until elective replacement indicator (eri)=yes. The manufacturer's consultant later reported that the patient always has a reaction like grabbing her throat when a lead test is performed or a magnet is swiped. She reported that the physician does not know the cause of the patient's events including the increase in seizures. It is unknown if the cause could be stimulation being higher or a potential lead issue so they are going to prophylactically replace the whole system since it is nearing end of service, the lead has been implanted for so long, and they are unsure why the patient is having these events. The physician has since decreased the patient's pulse width to 130usec. The physician also reported that he believes that the patient is exaggerating the events for attention. Although surgery is likely, it has not yet occurred.

 
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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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2377262
Report Number1644487-2011-03112
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/23/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/05/2002
Device MODEL Number300-20
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/22/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/30/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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