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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171); Chest Tightness/Pressure (2463)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported on (b)(6) 2014 that the patient reported pain near the generator that persisted mildly even when the device was off for several months.The patient did not believe it improved his seizures, although the surgeon¿s nurse indicated that it may have after it was initially implanted.The patient¿s device was explanted on (b)(6) 2014.The explanted device could not be returned for product analysis as the hospital does not return.Good faith attempts for further information were unsuccessful.It had been reported on (b)(6) 2014 that the patient was on low settings, output=0.25ma, and felt a pressure in the chest and tingling in the left arm.The physician didn¿t know if the issues were related to the vns.

Event Description

Additional information was received from the treating physician.He reported that the patient had reached decent settings and requested that his devices get turned off as it was felt to not be helping.The physician reported that the patient was a non-responder.Then, after aed polytherapy failed to improve his seizure control, the physician suggested to turn on his device as it has no role when not active.Once the patient agreed, he displayed a high sensitivity to very low initial stimulations and responded with coughing immediately upon an adjustment that he could not tolerate.Thus, this precipitated the patient¿s requests for a vns removal.The physician reported that this may have represented a psychological response and lack of motivation, but that it was speculative.

Manufacturer Narrative

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not report this outcome, as explant occurred.

Event Description

Patient reported further information related to the device shocking (painful stimulation) him.It was noted that the physician changed the patient's settings and resulted in a shock that startled the patient.The device was then noted to have been turned off and the patient reported feeling a shock upon the device disablement.The patient reported that this resulted in the device removal.

Event Description

Further information was received that the patient's neurologist did not know specifics of what the patient meant by the report of: is burnt can't be removed from my c5 nerve; the metal part can't be taken outta my chest; the physician confirmed that only the generator was initially removed.The patient wanted to receive an mri therefore the patient's surgeon performed a second surgery to remove the lead.Further information was received from the patient's surgeon that the patient underwent generator explant on (b)(6) 2014 as well as removal of the distal portion of the lead.On (b)(6) 2019, the patient underwent surgery to remove more of the lead due to patient desire for an mri.The surgeon's office did not discuss a burn; or anything related to c5 with the patient.

Event Description

Social media post made by the patient indicated that the device shocked him hard when turned off.The patient also reported that he could only get the battery and part of the lead/wire taken out of him.The patient also stated that the main wire is burnt can't be removed from my c5 nerve; the metal part can't be taken outta my chest.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4191919
• MDR Text Key: 4962396
• Report Number: 1644487-2014-02774
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2008
• Device Model Number: 102
• Device Lot Number: 015227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2006
• 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): Other; Required Intervention
• Patient Age: 32 YR