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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/26/2008

Event Type  Injury  

Event Description

A patient reported that his vns device had been removed prior due to painful stimulation and voice alteration.The patient's explant had previously been reported and was due to unknown reasons.The generator was returned for product analysis and verified that the generator performed according to all functional specifications and was able to adequately provide the intended therapy while placed in a simulated body environment.A review of the manufacturing records and diagnostic history also indicated proper device functionality.Follow-up was performed with the explanting facility, but no further relevant information was able to be received.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6394773
• MDR Text Key: 69608488
• Report Number: 1644487-2017-03359
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/10/2017

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: 08/31/2008
• Device Model Number: 102
• Device Lot Number: 014007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2008
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2005
• 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: 40 YR