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

Model Number 102

Device Problems Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problem Weight Changes (2607)

Event Date 05/14/2014

Event Type  Injury  

Event Description

It was reported that the vns patient¿s generator had migrated downward which caused some difficulty for the psychiatrist to locate and interrogate the device.The psychiatrist was eventually able to palpate the device.The patient did not have any discomfort.Further follow-up revealed that the psychiatrist was no longer able to communicate with the patient¿s device due to migration.There were no issues with the programming system.The patient¿s generator had migrated over the years and had gotten deeper into the patient as she gained weight.The physician stated that the generator migration was due to the patient¿s weight gain and not a suture issue.The device was reported to be functioning.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014.The explanting facility discarded the explanted device; therefore, no analysis can be performed.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3856875
• MDR Text Key: 4617542
• Report Number: 1644487-2014-01443
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

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: 07/31/2007
• Device Model Number: 102
• Device Lot Number: 013834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 06/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2005
• 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: 28 YR