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

Model Number 102

Device Problem High impedance (1291)

Patient Problems Muscle Spasm(s) (1966); No Consequences Or Impact To Patient (2199); Cognitive Changes (2551)

Event Date 07/14/2015

Event Type  malfunction  

Event Description

During review of programming and diagnostic history, it was observed that the patient's vns device was testing during an office visit on (b)(6) 2015 and system diagnostics revealed high impedance (dc dc - 6).The device was evaluated again on (b)(6) 2015 and system diagnostics revealed high impedance again on that date (dc dc - 6).No patient adverse events have been reported and no known surgical interventions have occurred to date.Attempts for further relevant information have been unsuccessful to date.

Event Description

Information received on 06/09/2016 states that the patient was last seen (b)(6) 2016 and lead impedance was ok.The patient has had no adverse events that may be associated with the high impedance.X-rays have not been taken and patient manipulation or trauma is not expected to be related.The physician's office is aware that there may be a fluctuating high impedance issue so the patient was referred to neurosurgery.No further relevant information has been received to date.

Event Description

It was reported by the patient's mother that the patient's head had been shaking and that the patient was acting differently.The neurologist indicated that the patient had not been acting the same on her current generator as she had on her previous generator, so she was referred for surgery consult for symptom assessment and a lead check.After the consult, the patient was scheduled for surgery.Per the manufacturer's programming database, high impedance was detected again on this patient's device within the last year.No further relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

It was reported through implant card that the patient underwent planned lead and generator replacement surgery due to high impedance and prophylactic replacement.However, during surgery, it was determined that replacing the generator solved the issue.The lead pin was not re-inserted into the old, explanted generator to ensure that the pin was past the connector block with a good electrical connection.No further relevant information had been received to date.The suspect product has not been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 5672077
• MDR Text Key: 46724107
• Report Number: 1644487-2016-01093
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 102
• Device Lot Number: 3938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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: 32 YR