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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 07/24/2013
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery for ifi = yes a high lead impedance (dc dc code 7) was obtained once the new generator was connected to the existing lead. The lead was removed from the new generator and reinserted to ensure proper connection and device diagnostics again resulted in high lead impedance (dc dc code 7). It was reported that diagnostics prior to the case showed no lead issues. A lead revision was not performed at that time due to consent not being obtained for lead revision prior to the procedure. The surgeon will consult with the patient prior to lead revision. It was reported that the device remained programmed off after the surgery. No patient manipulation occurred that could have caused or contributed to the high impedance reading. No x-rays have been taken as the surgeon was going to consult with the neurologist. Surgery is likely; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Product analysis was completed on the generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

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

 
Event Description

The patient's vns device was replaced on (b)(6) 2013 and the explanted device was returned to the manufacturer. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 178mm portion the (-) unmarked connector pin quadfilar coil appeared to be broken approximately 75mm from the connector bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 178mm portion the (+) marked connector pin quadfilar coil appeared to be broken approximately 56mm past the end of the outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and a secondary break line. During the visual analysis of the returned 184mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken approximately 3mm from the end of the abraded open / cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. During the visual analysis of the returned 184mm portion quadfilar coil 2 appeared to be broken approximately 16mm and 22mm from the end of the abraded open / cut / outer / inner silicone tubing. The coil breaks were observed inside the extending portion of inner silicone tubing 2. After the cleaning process determination could not be made between the two coil break areas. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type. During the visual analysis of the returned 184mm portion the opposite end of quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage, no pitting and a secondary break line. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur, chlorine and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the 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 at one time. 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. The setscrew marks found on the unmarked connector pin provides 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 other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

(b)(4) date of event, corrected date: previously submitted mdr indicated that the event date was (b)(6) 2013; however, this should be (b)(6) 2013. This report is being submitted to correct this data. Date of this report, corrected data: previously submitted mdr indicated that the aware date was 07/25/2013; however, this should be 07/24/2013. This report is being submitted to correct this data.

 
Event Description

Additional programming history was reviewed. Review of data for the generator that was implanted on (b)(6) 2013 showed high impedance during three system diagnostics on the date of implant. A generator diagnostic with a test resistor was within normal limits indicating that the lead was likely the cause of the high impedance. Review of decoder data from the generator explanted in (b)(6) 2013 shows that based on the last internal automeasure of the device on (b)(6) 2013, the impedance was 3062 ohms; therefore, the high impedance likely occurred on (b)(6) 2013.

 
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Brand NameLEAD 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 Key3295171
Report Number1644487-2013-02454
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 07/24/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2000
Device MODEL Number300-20
Device LOT Number16617C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/19/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/02/1998
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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