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

Model Number 103

Device Problems Migration or Expulsion of Device (1395); Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

A nurse at the treating physician's office reported that the reason for the magnet stimulation not perceived was due to the patient not swiping the magnet over the generator area.Once they were able to locate the generator, the patient was able to feel magnet stimulation.There was no report of normal mode stimulation not perceived.The generator was located more medially and lower than the patient and staff thought.The patient has a lot of soft tissue and is of large stature.The nurse was unable to provide additional information on the increased seizures.No interventions were reported.The patient has been doing well.

Event Description

Additional information was received stating that vns patient¿s issues had resolved.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported that the vns patient was experiencing an increase in seizures, was unable to perceive stimulation, had pain at the electrode site, and had a ¿hard mass¿ in the generator pocket.Follow-up revealed that the patient¿s generator was tested and diagnostic results showed normal device function.No trauma was reported to have occurred.The patient¿s device reportedly had migrated south but was not causing any harm to the patient.The patient had her magnet taped over her device to improve her voice hoarseness and gagging; however, the pain in the patient¿s neck did not resolve.X-rays dated were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The patient¿s magnet was taped over the generator so an assessment cannot be made in regards to the filter feed-through wires and the lead connector pin.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4101231
• MDR Text Key: 5302762
• Report Number: 1644487-2014-02386
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2014

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: 12/31/2012
• Device Model Number: 103
• Device Lot Number: 201679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2014; 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2011
• 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: 52 YR