MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Weakness (2145); Tingling (2171)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2014 note that the patient reports that the vns wires shock her even when the device is off.The patient indicated that she feels like she has lost all use of her left side.It was noted that the patient suffered a fall on (b)(6) 2014, striking the area near the vns.There was no bruising or edema that resulted from the trauma.The patient begun to complain of weakness in her left arm and occasional tingling in her left leg.It was noted that this has not impacted the patient's activity level.The physician programmed the device off on (b)(6) 2014 and x-rays were performed to check for possible damage or movement of the vns caused by the fall.The physician referred the patient to the surgeon because he believed the device has migrated significantly lower than initially placed.The physician reported that he felt the device had migrated some time ago because an x-ray from (b)(6) 2014 showed the device in the same location as the current x-ray.The patient underwent prophylactic generator replacement.Attempts to obtain additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 4348399
• MDR Text Key: 5142726
• Report Number: 1644487-2014-03431
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/17/2011
• Device Model Number: 104
• Device Lot Number: 2635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2010
• 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: 44 YR