MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problems Seizures (2063); Ambulation Difficulties (2544)

Event Date 07/15/2015

Event Type  malfunction  

Event Description

It was previously reported that the patient¿s generator had reached eos and was pulse-disabled due to the eos condition.Device diagnostics were performed and were noted to be within normal limits.The patient was referred for generator replacement.It was subsequently reported that the patient was experiencing more balance issues and small seizures.The reporter of this information was aware the generator was at end of service and appeared to attribute the experience to the condition of the generator.One of the patient¿s group home providers had questioned why the generator appeared to deplete quickly.Review of the vns physician¿s manual showed a predicted time of 3.6 years from beginning of life to end of service for settings and diagnostics similar to the patient¿s results.The device history record of the generator was reviewed by the manufacturer.It was found that all quality tests passed prior to distribution.Review of the record also showed that the generator was manufactured using a laser routing procedure.Review of the available internal device data from the date of implant did not reveal any anomalies.The patient¿s vns generator was replaced in surgery.The generator was received by the manufacturer and is undergoing analysis.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted.The unit had failed to interrogate at 1 inch, but successfully interrogated at 0 inch spacing.The bench interrogation showed the generator was disabled from the battery voltage being at end of service (eos) levels.The generator pulse current would not reset.With the generator case removed and the battery still attached to the printed circuit board, the battery measured 1.641 volts, confirming an eos condition.Contaminants were observed on the edge of the circuit board.The internal device data showed 33.504% of the battery had been consumed.With the battery removed, electrical testing on the circuit board showed that the several electrical current tests had failed.With the use of fine grit sandpaper and isopropyl alcohol to remove observed contaminates from the trimmed edge of the circuit board, these previously failed tests subsequently passed.Product analysis concluded that the remaining residual material on the printed circuit board edge after the test tab was removed in the manufacturing process resulted in increased current consumption and likely contributed to the premature eos condition.Information from the available programming history and internal device data during the use life of the generator was consistent with these observations.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6647088
• MDR Text Key: 77767708
• Report Number: 1644487-2017-03986
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2017
• Device Model Number: 106
• Device Lot Number: 203429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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 Outcome(s): Other
• Patient Age: 60 YR