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

Model Number	300-20
Medical Device Problem Codes	Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260); High impedance (1291); Mechanical Problem (1384)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	01/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the company representative that high impedance was detected during generator replacement surgery after a new model dual-pin generator was connected to the lead.The generator was replaced due to migration and no communication due to battery depletion as captured in mfr.Report # 1644487-2016-02759, when the generator migrated, the physician indicated that he believed the lead may have a strain relief issue due to the migration.Pin insertion troubleshooting was attempted but did not resolve the high impedance.The or specialist indicated that the didn't see a fracture but that he had that seen the wire near the electrodes bent at a 90 degree angle.He also reported that the lead was not implanted with proper strain relief.Additionally, there was a lot of scarring that made it difficult to remove the lead.The patient's lead was replaced.The suspect lead was received by the manufacturing facility for product analysis.No additional relevant information has been received to date.
Event or Problem Description
Product analysis was completed on the suspect lead.The lead was returned in multiple segments.The negative electrode and an unknown portion of the inner silicone tubing and quadfilar coil were not received.Setscrew marks on the lead pins indicated that at one point in time there was good mechanical and electrical connection between the generator and lead.An abraded opening in the outer tubing was found along with fluid inside the inner and outer tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.The report of a kinked coil was also verified.Three lead breaks were found.The first break identified was after the lead bifurcation at an abraded opening.Pitting on the coil surface was found.The second lead break was found in the area of lead near the electrodes after the lead bifurcation.One strand of the fractured lead was identified as fatigue-induced.Fine pitting was observed on one side of the fracture.The third lead break was found at the proximal end of the anchor tether.It was believed that stimulation to the patient with the lead break was present for a certain period of time due to the presence of metal pitting on this coil's surface.No other obvious anomalies were noted.No further relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Common Device Name: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 6302578
• Report Number: 1644487-2017-03027
• Device Sequence Number: 14488813
• Product Code: LYJ
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/23/2004
• Device Model Number: 300-20
• Device Lot Number: 7910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Event Location: Other
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR