MAUDE Adverse Event Report: CYBERONICS, INC.VNS THERAPY PULSEPULSE GENERATOR

Model Number 102

Event Date 01/01/2004

Event Type  Injury   Patient Outcome  Required Intervention

Event Description

Patient's wound dehisced some time after suture removal following implant surgery. The patient was reportedly seen in hospital emergency room, at which time the wound was "sewn back up. " at recent office visit, treating neurologist indicated that he could not palpate the generator. Review of subsequent chest x-ray revealed that no generator was present in the chest along with no evidence of the lead. Investigation to date has been unable to determine the location of the devices or whether the patient removed the lead and/or generator through the incision sites. The patient's family member has reportedly searched their home for the lead and generator with no success. Repeat x-rays and follow up with neurosurgeon are planned. Investigation to date has been unable to determine the cause of the reported wound dehiscence.

• Brand Name: VNS THERAPY PULSE
• Type of Device: PULSE GENERATOR
• Baseline Brand Name: VNS THERAPY PULSE
• Baseline Generic Name: PULSE GENERATOR
• Baseline Catalogue Number: NA
• Baseline Model Number: 102
• Baseline Device Family: NA
• Baseline Device PMA Number: P970003
• Baseline Shelf Life Information: Yes
• Is Baseline 510(K) Number Provided?: No
• Baseline Preamendment?: No
• Transitional?: No
• 510(K) Exempt?: No
• Shelf Life(Months): 24
• Date First Marketed: 06/20/2002
• Manufacturer (Section F): CYBERONICS, INC.; houston TX *
• Manufacturer (Section D): CYBERONICS, INC.; houston TX *
• Manufacturer Contact: darlene garner, rac ; 100 cyberonics blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 562878
• MDR Report Key: 573008
• Event Key: 544592
• Report Number: 1644487-2005-00084
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2005

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/15/2005
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: 102
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2005
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes

Is this an Explanted Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 02/15/2005 Patient Sequence Number: 1

#	Treatment	Treatment Date
MODEL 302-30 VNS THERAPY LEAD