MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pain (1994); Neck Pain (2433); No Code Available (3191)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing pain, device protrusion and generator migration following a mammogram procedure.The pain and protrusion were stated to be at both the lead and generator sites.The patient stated that she was thin and that her lead was always visible, but since the mammogram it protruded more than it had previously.A revision surgery was reported to have been scheduled at the time of the report, but has not been known to occur to date.No additional pertinent information has been received to date.

Event Description

It was reported that the patient had a revision surgery on (b)(6) 2016.The generator found to be "completely floating around" in the generator pocket and was "upside down".It was reportedly loose enough that the surgeon could spin it in a circle.During the surgery, the surgeon observed that a tie-down was not attached and was re-attached.The generator was also re-secured, and more slack was given in the neck for the lead.In the previous generator implant, the surgeon reportedly did not place a suture to secure the generator.The patient did not have an issue with vns placement until the mammogram.No additional pertinent information has been received to date.

Event Description

The patient reported that the stabbing pain she previously reported was still present.Her vns was subsequently turned off.The pain in the neck was reported to have resolved with the generator disabled.The patient reportedly still experienced occasional sharp pain at the generator site not coinciding with stimulation.This pain cannot be predicted and does not appear to happen with any specific movement or body position.The patient expressed that she wanted the generator explanted.She feels the m106 generator is too large for her thin body.No known additional surgical intervention has occurred to date.No additional relevant information has been received to date.¿.

Event Description

Follow up with the office of the surgeon who performed the revision surgery showed that he likely used a suture to secure the generator in the previous generator replacement surgery.Attempts for additional pertinent information regarding the revision surgery have been unsuccessful to date.Further information showed that the patient was still experiencing pain and ¿shocking¿ sensations.The device was reported to be off at the time of this report.No additional pertinent information has been received to date.

Event Description

The patient was reportedly still experiencing pain.The device was reported to still be set to not deliver current at the time the patient experienced the pain.No additional pertinent information has been received to date.

Event Description

It was reported that the patient had her vns generator and lead explanted due to discomfort and painful stimulation.The explanted devices have not been returned to the manufacturer to date.No additional pertinent information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Communication from the treating physician showed that the patient¿s pain had continued following cessation of stimulation.Settings and device diagnostic results were provided from the appointment where the device was disabled.The physician reportedly endorsed that the pain began following a mammogram procedure which pulled the vns lead.The explanted lead and generator were received by the manufacturer for product analysis.Product analysis was completed on the returned lead portion.The returned portion measured 336 mm.The continuity measurements taken during decontamination verified an electrical and mechanical contact between the generator and the connector block to the end of lead.Visual analysis showed that the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.The set screw marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at least at one time.Continuity checks of the returned lead portion were performed and no discontinuities were identified.There is no evidence to suggest an anomaly with the returned portion of the device.Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device.The device output signal was monitored for more than 24-hrs in a simulated body temperature environment.The pulse generator showed expected level of output currents and no signs of variation.Both interrogation and system diagnostic tests were performed.Various electrical loads were attached to the pulse generator, and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 3.051 volts during functional testing and showed an ifi=no condition.The internal device data showed that 12.492% of the battery had been consumed.Review of the remainder of the internal device data showed no anomalies.There were no performance or any other type of adverse conditions found with the pulse generator.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 5909344
• MDR Text Key: 53290335
• Report Number: 1644487-2016-01941
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2017
• Device Model Number: 106
• Device Lot Number: 203600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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: 48 YR