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

Model Number 103

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Headache (1880); Pain (1994); Burning Sensation (2146); Seizures, Focal (2260); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet.The patient felt five constant jolting sensations at her generator site every few minutes.The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation.Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately.At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand.The patient taped her magnet over her generator but continued to feel pain and jolting sensations.The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes.When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red.The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014.The pain and redness subsequently resolved.The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms).The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control.The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013.Since her device was disabled, the patient experienced six generalized seizures.The patient underwent generator and lead replacement surgery on 05/20/2014.The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery.The explanted devices have not been returned to date.

Event Description

It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description

Good faith attempts for further, relevant information have been unsuccessful.It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.

Event Description

Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery.The explanted generator was returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the generator was completed on (b)(4) 2014.An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant.A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.It was reported that the surgeon told the patient that the generator was "fried".It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used.Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery.An implant card received confirmed that only the generator was replaced.

Manufacturer Narrative

Only the generator was replaced.

Event Description

Additional information was received that the patient's generator could never get regulated correctly.It is suspected that the regulation of the device refers to titration.Available programming history for the generator was reviewed.The patient's device was disabled the day of explant.Diagnostics at that time were within normal limits.After implant of the device, it was titrated to 0.25 ma and the output current was increased up to 1.5 ma a few months later.However, the settings were reduced down and disabled shortly after.

• 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: 3845253
• MDR Text Key: 4406009
• Report Number: 1644487-2014-01384
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Model Number: 103
• Device Lot Number: 3590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 12/02/2017
• Supplement Dates FDA Received: 07/01/2014; 08/04/2014; 09/04/2014; 10/20/2014; 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2013
• 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): Required Intervention
• Patient Age: 22 YR