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

Model Number 102

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Discomfort (2330); Weight Changes (2607)

Event Date 09/09/2014

Event Type  Injury  

Event Description

Initially, it was reported that the patient¿s generator and leads are clearly visible under the surface of the patient¿s skin.It was mentioned that the patient has lost weight since implantation and the device appears to have migrated.The patient mentioned that it ¿gets caught on things¿ and can almost flip over under the skin.The patient is interested in explanting the device and is speaking with her psychiatrist to have a referral to her original implanting surgeon for an explant.The patient mentioned that her psychiatrist programmed the device off years ago since her medications were more effective than vns therapy.Further follow-up revealed that the patient was referred for surgery for explant.The physician indicated that the explant was being performed due to patient comfort and to preclude a serious injury.No known surgical intervention have been performed to date.

Manufacturer Narrative

• 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: 4250609
• MDR Text Key: 5107250
• Report Number: 1644487-2014-03026
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2014

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: 06/30/2007
• Device Model Number: 102
• Device Lot Number: 013894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2005
• 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): Required Intervention
• Patient Age: 57 YR