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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Irritation (1941); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 01/01/2013

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing a ¿shocking¿ and tightness sensation in the neck, possibly due to the strain-relief being lost as the patient grew up.System diagnostics returned impedance within normal ranges.Review of the available programming and diagnostic history showed device disablement on (b)(6) 2011.The patient¿s mother believed that vns therapy was made the patient¿s epilepsy worse, whether it was on or off, as it was irritating the patient.It was therefore decided to explant the vns system without replacement.The patient's device was explanted on (b)(6) 2013.The explanted devices have not been returned to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 4664019
• MDR Text Key: 17693634
• Report Number: 1644487-2015-04342
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2006
• Device Model Number: 102
• Device Lot Number: 010275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2004
• 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: 23 YR