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

Model Number 106

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 09/26/2017

Event Type  Injury  

Event Description

It was reported that a patient was hospitalized due to a rash of seizures.Upon doing system diagnostics, the physician reported he saw high lead impedance.He would like this patient to be expedited for a lead revision due to the increase in seizure activity.Revision surgery occurred.The explanted devices have not been received by the manufacturer to-date.Additional relevant information has not been received to-date.

Event Description

Follow-up to the company representative who attended the surgery provided that during the surgery the lead pin was re-inserted.The impedance was shown to be normal after the lead pin re-insertion, however the surgeon elected to replace the lead anyway.There was no fracture or break identified in the surgery.

Event Description

It was reported that the explanted lead was discarded.

• 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: 6967577
• MDR Text Key: 90536564
• Report Number: 1644487-2017-04657
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: 106
• Device Lot Number: 204027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/21/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 11/16/2017
• Supplement Dates FDA Received: 11/16/2017; 12/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2008
• 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: 57 YR