MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (5348 ohms).The generator was programmed off and x-rays were taken.It was reported that the patient has been digging at the incision site since implant.It was reported that the patient was recently implanted.The patient was seen by the physician again and device diagnostics were performed which resulted in impedance values from 5200 ohms to high in the 5000 range.The physician indicated that the x-rays were ok.X-rays were sent to manufacturer for review.Based on the x-rays received, it appears that the lead pin not being fully inserted may be the cause of the device¿s high impedance.There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out.As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed.Surgery is likely, but has not been performed to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

Event Description

It was reported that the patient underwent revision surgery at which time the lead pin was reinserted into the generator header.It was reported that device diagnostics after the lead pin was reinserted was within normal limits (2888 ohms and 2740 ohms).

• Brand Name: PULSE GEN MODEL 105
• 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: 3910595
• MDR Text Key: 4489883
• Report Number: 1644487-2014-01673
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/04/2014

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: 12/31/2015
• Device Model Number: 105
• Device Lot Number: 3817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• 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 Age: 12 YR