MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Corroded (1131); High impedance (1291); Pitted (1460)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

Initially, it was reported that high impedance was observed and the patient was experiencing an increase in seizures.It was reported that the patient had recently suffered a fall during ice skating.The physician assistant believes the device was damaged during the fall.X-rays were taken and sent to manufacturer for review.X-rays identified that the lead pin did not appear to be fully inserted into the generator header.The patient underwent surgery.The surgeon opened the chest pocket to check the connection and when the generator was removed the lead pin fell out of the header confirming a generator/lead connection issue.The surgeon implanted a new generator and lead.The explanted lead and generator were received for analysis.Analysis of the lead was completed on (b)(4) 2015.During the visual analysis of the returned 289mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface.Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector pin.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin rust-like deposit and identified the area as consisting of chromium, iron, nickel, silicone and phosphorus.Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, sodium, manganese, silicone and sulphur.A definite cause for the pitting could not be determined based on the lead portion returned.No other obvious anomalies were noted except for the set of setscrew marks found near the end of the 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 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.Analysis of the generator was completed on (b)(4) 2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no additional performance or any other type of adverse conditions found with the pulse generator.The generator decoder identified that the high impedance occurred prior to (b)(6) 2014.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 4576543
• MDR Text Key: 5453346
• Report Number: 1644487-2015-04063
• 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 Assistant
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 103
• Device Lot Number: 3836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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: 18 YR