MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems High impedance (1291); Battery Problem (2885); Device Operates Differently Than Expected (2913)

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

Event Date 09/01/2013

Event Type  malfunction  

Event Description

The physician reported that the patient may have an issue with the device, but no additional details were provided.It was later reported that the patient will be referred to surgeon for possible revision because the device showed high impedance and end of service.The patient underwent generator and lead replacement on (b)(6) 2013.The lead and generator were returned to manufacturer for analysis.An implant card was received indicating that the patient underwent lead and generator replacement due to "lead discontinuity".Analysis of the generator was completed on (b)(6) 2013.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.Analysis of the lead was completed on (b)(6) 2013.Note that a portion of the lead assembly 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 344 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm and 3 mm from the connector bifurcation.Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 2 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting.Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 3 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting.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 (-) unmarked inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids found inside the outer and (-) unmarked inner silicone tubing.For the observed (+) marked connector pin inner tubing remnants of what appeared to have once been body fluids found inside, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.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, potassium, zirconium, sulphur and calcium.Refer to attached eds sheet for additional information.The slice and puncture marks observed on the inner silicone tubes (past the electrode bifurcation) appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed.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 pins 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.

Manufacturer Narrative

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

• Brand Name: BIPOL LEAD MODEL 300
• 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: 3551516
• MDR Text Key: 4102892
• Report Number: 1644487-2014-00058
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2005
• Device Model Number: 300-20
• Device Lot Number: 8280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2013
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2003
• 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: 35 YR