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

Model Number 302-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); High impedance (1291)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2015

Event Type  malfunction  

Event Description

It was reported on 11/11/2015 that the patient had an end of service replacement that day.The physician was unable to interrogate the generator.When the new generator was connected to the existing lead, high impedance was observed around 8000 ohms.The lead was disconnected and reinserted.The physician verified that the lead pin was advanced beyond the connector block and the set screw was tightened down.Impedance was measured again and the value was over 8000 ohms.The surgeon was not able to replace the lead that day.The old lead remained connected to the new generator and the generator was left at 0.0 ma.The explanted generator was discarded after surgery.Replacement of the lead is expected but has not been completed to date.

Event Description

It was reported on (b)(6) 2015 that the patient had a follow-up appointment on (b)(6) 2015 and the patient no longer has high impedance.Since intermittent impedance or a microfracture cannot be ruled out, the patient's device may still be malfunctioning.No additional relevant information has been received to date.

Event Description

Programming history database was reviewed on (b)(6) 2016 for the recently received model 106 generator data.History was available from date of implant, (b)(6) 2015.The system diagnostics were performed 5 times and each time resulted in high impedance.(b)(6) 2015: 8:41:57 am - ok/ok/8894/ok; (b)(6) 2015: 8:43:15 am - ok/ok/8523/ok; (b)(6) 2015: 8:47:17 am - ok/ok/9039/ok; (b)(6) 2015: 8:55:56 am - ok/ok/9026/ok; (b)(6) 2015: 8:56:38 am - ok/ok/5980/ok.

Event Description

Information was received 08/08/2017 that the patient¿s device was found to have high impedance in the 6,000 ohms range.X-rays were received and reviewed but could not conclusively identify a cause of the high impedance.

Event Description

X-rays were received and review showed there is a sharp angle in the lead body observed just proximal from the generator implant site.Full revision surgery occurred.Impedance was high in pre-op.The surgeon removed the battery and re-inserted the pin but the impedance was still high.The battery was tested alone with the test resistor, and the impedance was within normal limits.The explanted devices have not been received by the manufacturer to-date.

Event Description

Further information was received that both the generator and lead were returned to the manufacturer.Product analysis was completed on both products.Analysis on the generator did not find any anomalies.The generator performed according to all specifications, and besides markings associated with explant, no visual abnormalities were noted.Data from the generator was also reviewed.High impedance was seen on the day of explant.Product analysis on the lead identified multiple coil breaks along the returned lead body.Scanning electron microscopy was performed and identified some areas as being mechanically damaged which prevented identification of the coil fracture type.Scanning electron microscopy also identified some of the fractures of being stress induced by fatigue or rotational stress.Pitting was also observed on some of the various broken coils indicating stimulation was likely present at one point.Residual material was observed on one of these broken coils.Multiple abraded openings were also noted on the outer tubing.There were also areas of abraded openings in the inner tubing near some of the fractures.This allowed fluid to breach the inner and outer tubing.White deposits were also noted along the lead body.With the exception of the observed abraded openings and discontinuities the condition of the returned lead portions was 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.The electrodes were not returned and analysis could not be completed on that portion of the lead.No further relevant information has been received.

• 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: 5260887
• MDR Text Key: 32789893
• Report Number: 1644487-2015-06626
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/08/2017; 09/13/2017; 11/02/2017
• Supplement Dates FDA Received: 01/04/2016; 03/18/2016; 08/31/2017; 10/06/2017; 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• 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: 47 YR