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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 10/23/2014
Event Type  Malfunction  
Event Description

It was reported that the patient was seen by the nurse practitioner due to an increase in seizure activity. It was reported that device diagnostics resulted in high impedance. The device output current was decreased from 2ma to 1. 5ma. The patient was sent for x-rays. Further follow-up revealed that device diagnostics on (b)(6) 2014 were within normal limits. The patient underwent generator replacement on (b)(6) 2014 and post operative device diagnostics were within normal limits. It was reported that the increase in seizures is thought to be due to a loss of vns therapy. The seizures were not back to the patient's pre-vns baseline frequency. There were no external factors that are believed to have caused or contributed to the high impedance. Clinic notes dated (b)(6) 2014 note that device diagnostics showed high impedance. Surgical clinic notes dated (b)(6) 2014 note that the patient had been doing very well with decreased seizure frequency until more recently and that high impedance was observed by the neurologist. It was noted that device diagnostics were again performed which indicated high impedance (6475 ohms). It was noted that the patient will undergo lead replacement with possible generator replacement due to device compatibility. The device was programmed off. No known surgical interventions have been performed to date.

 
Event Description

It was reported that the patient underwent generator and lead replacement on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
Manufacturer Narrative

Corrected data: this information was inadvertently left off of follow-up mfr. Report #02.

 
Event Description

Analysis of the lead was completed on 01/13/2015. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil at the suspected torn end located at the 1st portion of the returned lead show that a stress-induced fracture (due to rotational forces) has occurred on the coil wires. Although not conclusive secondary fractures noted in the vicinity of the broken end suggest the stress-related primary fractures were most likely created during the explant procedure. Scanning electron microscopy images of the negative coil at the second portion show that pitting or electro-etching conditions have occurred at the coil end and at the area where a dark appearance was noted. Due to metal dissolution and surface contamination a conclusive determination of the fracture mechanism cannot be made. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the generator was completed on 01/19/2015. 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.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

 
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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 Key4319221
Report Number1644487-2014-03251
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2003
Device MODEL Number300-20
Device LOT Number3359
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/15/2001
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: 12/10/2014 Patient Sequence Number: 1
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