MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Failure to Interrogate (1332); Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Event Description

During a generator replacement surgery, the old generator was unable to be interrogated.When the lead was connected to the new generator, high impedance was observed.The company representative performed 3 system diagnostics in a row.Each time, the output current was low, current delivered was 0.25ma, and lead impedance was high >=10000 ohms.The old lead pin was fully inserted into the m 103 prior to system diagnostics.The surgeon looked under magnification to confirm, then disconnected lead, inspected lead and insertion point and confirmed again.High impedance was still present after confirming complete insertion.A full revision surgery was performed as a result.With the new lead connected to the new generator, impedance was within normal limits.The explanted lead has not been received to date.

Event Description

The generator and lead were received.Analysis is underway but has not been completed yet.

Manufacturer Narrative

(b)(4).

Event Description

The reported ¿end of service and low battery¿ allegations on the generator were confirmed in the lab; an open can measurement of the battery voltage determined that the battery was depleted.The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found.An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance were confirmed.A portion of the outer silicone tubing and a portion of the connector ring quadfilar coil were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned lead, the lead coils appeared to be broken in several areas.Scanning electron microscopy performed on the several coil breaks identified the areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, some with pitting and some without pitting, evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands.The area on one of the two remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type.The area on the last broken coil strand was identified as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.During the visual analysis of the returned 15mm portion the (-) green quadfilar coil appeared to be broken approximately 3mm past the end of the cut / torn inner silicone tubing.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 slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing.What appeared to be white deposits were observed in various locations.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the inner silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium.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.The setscrew marks found on the lead 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 other discontinuities were identified.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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 Key: 6179592
• MDR Text Key: 62865781
• Report Number: 1644487-2016-02885
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2006
• Device Model Number: 302-20
• Device Lot Number: 010763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR