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

Model Number 102R

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 10/29/2015

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2015 noted that the patient complains of pain in her left arm, left leg and at time in the left side of her face for approximately 3 weeks.It was noted that the patient was unsure if the pain was coming from her vns.It was also noted that the patient noted there was a knot on her back where the generator is placed.The patient was referred to the surgeon to determine what the next step would be.It was later reported that the patient underwent generator replacement surgery.It was reported that the explanting facility does not return explanted devices for analysis; therefore, no product analysis can be performed.The surgeon indicated that the patient underwent generator replacement due to pain.The surgeon indicated that the pain was not associated with stimulation, but rather the presence of the device.Device diagnostics were within normal limits (dc dc -2).Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Further follow-up revealed that the patient determined that the pain was from a recent fall and was now feeling better.Generator replacement was done for patient comfort.The patient has not experienced any pain since generator replacement.Device diagnostics were within normal limits.

Manufacturer Narrative

Date of event; corrected data: this information was inadvertently reported incorrectly on the previous mfr.Report.

• Brand Name: PULSE GEN MODEL 102R
• 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: 5417620
• MDR Text Key: 37713907
• Report Number: 1644487-2016-00258
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2013
• Device Model Number: 102R
• Device Lot Number: 3006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR