MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Inadequate Pain Relief (2388); Neck Pain (2433)

Event Date 10/01/2016

Event Type  Injury  

Event Description

Initially, the surgeon's office reported that the patient was getting explanted because per the psychiatrist and patient, the device was not controlling her mood disorder and she has been having neck problems recently.They were planning to explant the lead, so the patient could get a neck mri.Later, it was reported that the patient tried to remove her vns system with a knife.She cut herself in the collarbone area.The patient was admitted to the er because she was bleeding.She did not reach or remove the device.The psychiatrist said that the patient said she tried to remove the device because it wasn't working and said that this was how the patient was.The surgeon reported that the patient removed it due to pain.The surgeon was unsure if the reported pain was due to actual pain or caused by her mental health.The surgeon did not believe anything was wrong with the vns to cause the pain.The patient received a full explant of lead and generator, reportedly due to lack of efficacy and need for a neck mri.No further relevant information has been received to date.No product has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6178449
• MDR Text Key: 62543140
• Report Number: 1644487-2016-02850
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Physician
• Type of Report: Initial
• Report Date: 12/13/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2007
• Device Model Number: 102
• Device Lot Number: 014675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2005
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR