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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 02/05/2013
Event Type  Malfunction  
Event Description

Product analysis on the leads was completed on (b)(4) 2013. The lead assembly body including the electrodes was not returned for analysis; therefore 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 portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the marked connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Product analysis of the generator was completed on (b)(4) 2013. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the pa lab. The battery is partially depleted, 2. 808 volts (near ifi) as measured during completion of the final electrical test. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The internal memory of the device stated that the impedance value went from 91 ohms to 22152 ohms on (b)(6) 2013 which is after explant.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(4) 2013 it was reported that the vns patient has high impedance. Diagnostics indicated that the device was only able to deliver 1. 0 ma despite being programmed to 3. 5 ma. It was also reported that the patient is experiencing an increase in seizures. Clinic notes dated (b)(6) 2013 were received. The clinic notes mention that the patient has vns and "sometimes it does work and there are other times where it will not work". The physician later clarified that this means that sometimes the magnet does not work to abort the patient's seizures and sometimes it does. High impedance was noted during this visit and the patient was having an increase in seizures. The clinic notes also mention that the patient's tremor is back, but not as severe as they used to be. The patient's guardian reported that the patient's seizures have changed and the patient has been experiencing more tremors in the last 2 years that the neurologist states are seizures. She states that sometimes the magnet works and sometimes it does not seem to help with breakthrough seizures. She did state that the patient is using different magnets than those provided for the vns. The caregiver mentioned that she believes that his seizures are overall better than baseline. The patient was referred for x-rays and surgery. The manufacturing records were reviewed for the lead and the device met all specifications prior to distribution. The physician later indicated that the increased seizures were first observed a couple of months ago but the high impedance was first observed on (b)(6) 2013. The physician stated that the increased seizures could be related to the vns. The physician has decided to have the device checked. The increase in seizures were noted to be below pre-vns baseline levels. The patient has been experiencing an increase in staring seizures. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. No patient manipulation or trauma occur that is believed to have caused or contributed to the event. The device was not disabled. Good faith attempts for the patient's lead product information from the implanting hospital were unsuccessful. Additional clinic notes were received dated (b)(6) 2013 that indicate the patient is having multiple seizures daily which include multiple different types of seizures. Vimpat was added along with depakote and keppra but despite these medications, the patient continues to have increased seizures. The patient underwent a full revision surgery on (b)(6) 2013 due to the high impedance and prophylactic generator replacement. The explanted generator and lead were returned for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed. A/p and lateral x-rays of the chest were received. The lead pins appeared to be fully inserted into the header of the generator. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, an exact cause for the report of high impedance could be determined. However, a small portion of the lead could not be visualized in the chest due to it being behind the generator and a portion of the lead in the neck could not be visualized in the views available. Also, the presence of a micro-fracture in the lead cannot be ruled out.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2986519
Report Number1644487-2013-00545
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2002
Device MODEL Number300-20
Device LOT Number39307C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/22/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/25/2000
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: 03/04/2013 Patient Sequence Number: 1
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