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

Model Number 102R

Device Problems Premature Discharge of Battery (1057); Migration or Expulsion of Device (1395)

Patient Problem Seizures (2063)

Event Date 11/03/2016

Event Type  Injury  

Event Description

It was reported by the physician that the patient was referred for generator replacement and possible lead revision with a new strain relief loop because the device had "fallen." it was reported through the neurologist's clinic notes dated (b)(6) 2016 that the patient's device slid down to the top of her left breast when she lifted her hands to fix her hair.Because of this, the device was reportedly now aggravating her.It was also noted that the physician was unable to interrogate her device which lead the physician to believe that the device was possibly no longer working.The patient's primary physician reported through clinic notes dated (b)(6) 2016 that the patient needed corrective surgery for her "broken" vns implant.He reported that the patient was having a seizure every 30 minutes that morning.Based on a battery life calculation on (b)(6) 2016, the patient has 0 years remaining until expected neos=yes, which indicates battery depletion.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient was referred for surgery for generator replacement and to revise generator placement.There was reportedly no trauma to cause the migration.The doctor reported that he believed the patient couldn't be interrogated due to end of service and that the patient was experiencing increased seizures attributed to loss of therapy.After the device migrated, it was also difficult to find.The patient reportedly could no longer feel stimulation after the migration occurred.With regards to the patient's strain relief loop, there was not a concern of a serious injury; it was reported that they want to confirm that the migration didn't affect the lead's strain relief.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The surgeon who initially implanted the patient's generator reported that he did not know whether he used a nonabsorbable suture to secure the generator to the fascia at time of implant.Per a received implant card, patient underwent a full revision of generator and lead surgery due to battery depletion and high impedance, which is captured in mfr.Report # 1644487-2017-03027.Follow up with the attending company representative reported that the patient's generator had migrated behind the patient's breast and could be moved 4-5 inches around.The patient reportedly could feel it moving every time she got up.The company representative was not able to interrogate the patient's generator either in or out of the body.He noted that the patient believed her generator had been dead for over a year and it hadn't been interrogated for over a year.No additional relevant information has been received to date.No product has been received to date.

Event Description

The patient's lead was returned and product analysis was completed on the device.Three fractures were identified, which are captured in mfr.Report # 1644487-2017-03027, but there was no obvious evidence to whether migration contributed to the one or more of the fractures.However, the suspect cause of the fractures was identified as due to wear, which suggests that the lead fractures were present prior to migration.The suspect product has not been returned to date.No further relevant information has been received to date.

Event Description

The suspect product was received for analysis.Product analysis was completed on the explanted generator and confirmed end of service, no communication condition.Post-burn electrical testing found that the generator performed according to functional specifications.No anomalies were identified.No further relevant information has been received to date.

• 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: 6143151
• MDR Text Key: 61401188
• Report Number: 1644487-2016-02759
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2009
• Device Model Number: 102R
• Device Lot Number: 017112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2007
• 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: 37 YR