MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Premature Discharge of Battery (1057); Use of Incorrect Control/Treatment Settings (1126); Device Dislodged or Dislocated (2923)

Patient Problems Bruise/Contusion (1754); Pain (1994); Tachycardia (2095); Vomiting (2144); No Code Available (3191)

Event Date 03/11/2016

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2016 indicate that the patient is experiencing a noise in her ear.Additional information was received that the patient woke up on (b)(6) 2016 while sleeping and could hear static and high pitched sound in her ear.Her generator site was hurting and her brain was foggy.The patient then visited the nurse practitioner on (b)(6) 2016.During the visit, the nurse practitioner was testing the magnet by swiping it and the patient felt like getting electrocuted as she had never needed to use the magnet before.Patient had bruising and tenderness in the chest and vomited due to the magnet stimulation.The nurse practitioner noted that the magnet stimulation pulse width was at 500 usec, which was very high compared to the normal stimulation.So the magnet pulse width was decreased down to be the same as normal stimulation.Diagnostics were performed and were within normal limits.X-rays were taken afterwards and no issues were observed.Patient also mentioned that the generator moved around and that it has been a while since this started (prior to (b)(6) 2016).Since the shock with the magnet, patient felt that her heart would beat really fast.This happens about once a day at different times of the day and can last 10-30 min.This heart beat increase is not occurring necessarily with vns stimulation and the vns stimulation doesn't make it better or worse.She never had this happen before and there are no triggers that patient could find.Patient was referred for generator replacement due to end of service of the device battery prior to the occurrence of these events.

Event Description

Additional information was received from the treating nurse practitioner that the patient's chest pain, high pitched sound in ear, and "foggy" brain were not occurring with vns stimulation.No known causes or contributory factors were present.Patient's increased heart rate or palpitations and other events are suspected to be associated with the higher pulse width of the magnet mode stimulation.The pulse width of the magnet mode stimulation was decreased from 500 usec to 130 usec to match the pulse width of the normal mode stimulation.Per the medical profession, there was no device migration as she could not perceive any movement of the generator.The pain in the chest was not due to presence of device or migration.Patient has had her generator replaced since then on (b)(6) 2016 and is doing well.The explanted device has not been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 5549412
• MDR Text Key: 41939776
• Report Number: 1644487-2016-00719
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2007
• Device Model Number: 102
• Device Lot Number: 012565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2005
• 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; Required Intervention
• Patient Age: 45 YR