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

Model Number 106

Device Problems High impedance (1291); Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Protective Measures Problem (3015)

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

Event Date 04/27/2017

Event Type  malfunction  

Event Description

A patient's generator could not be interrogated during a recent clinic visit.The patient's generator was implanted approximately 1.5 years prior to the clinic visit.A company representative was called, and 6 different programming systems were used to attempt an interrogation of the patient's generator; however, the generator still would not communicate.The programming systems could interrogate other generators in the same room.The patient's generator was easily palpable in the patient's thin chest, and interrogation was attempted at 0 and 1 inches from the generator.The patient was noted to beat on his generator, but it was unknown if this contributed to damage of the generator.Clinic notes reported that there were no indications of an end of service condition of the generator, as the patient coughed during a generator reset, and cleared his throat when the vns magnet was swiped over the generator.The physician believed that the patient was experiencing a firmware issue with the generator and referred the patient for generator replacement surgery.The nurse reported that the patient had not been seen by the physician's office for nearly 1 year, so the physician was concerned about the function of the patient's device.The nurse reported that the patient did not have medical procedures within the last year that required the use of electrocautery or similar surgical tools that could have come into contact with the generator and caused an unexpected discharge of battery.The nurse mentioned that there were no other explanations for the failure to interrogate besides the trauma the patient had inflicted on the device, but the medical staff was not sure that was truly the cause of the generator issues.A battery life calculation estimated 5.2 years life remaining until near end of service.Programming history was reviewed for the patient's generator and did not display evidence of premature battery depletion or any other abnormal conditions with the generator.The device history records were reviewed for the generator and revealed that the generator met all functional specifications prior to release for distribution.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

The patient underwent generator replacement surgery due to the failure to interrogate the generator.The explanted generator was received by the manufacturer for analysis, but analysis has not been approved for the device to date.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The company representative reported that the patient had always beat his chest incredibly hard on both the left and right sides, even prior to vns implantation.Analysis was approved for the returned pulse generator.The generator would not interrogate as received.Electrical testing and system diagnostics could not be performed due to the inability to interrogate the generator.A visual assessment of the internal circuitry identified that the negative battery voltage measurement post was dislodged from the battery and the circuit board.All of the filter feedthru wires were broken.A review of the manufacturing x-ray showed that the filter feedthru wires were connected appropriately at manufacturing.The manufacturer's logo on the battery component was observed to be atypically imprinted on the generator can insulator.The internal circuitry had rubbed on the battery case.Once the internal circuitry was connected to a bench power supply, the data could be downloaded; however, the data was corrupted due to the loss of the negative battery voltage measurement post.High impedance values were present in the data.Microscopy of the negative battery voltage measurement terminal suggested a stress-induced fracture occurred at the weld location.The exact fracture mechanism could not be ascertained.The force with which the patient struck his chest contributed to the extensive damage sustained by the pulse generator.No additional relevant 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: 7376480
• MDR Text Key: 103682696
• Report Number: 1644487-2018-00472
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

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: 04/13/2018
• Device Model Number: 106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/28/2018; 04/20/2018
• Supplement Dates FDA Received: 04/19/2018; 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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: 11 YR