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

Model Number 102

Device Problem Leak/Splash (1354)

Patient Problems Muscle Spasm(s) (1966); Seizures (2063)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that the patient had undergone lead replacement and a prophylactic generator replacement.Further information was received indicating that the patient had benefited from very good efficacy on seizure control with vns.The antiepileptic drugs were discontinued and the patient presented one or two seizures per year.The treatment for depression could be discontinued too.The patient¿s quality of life was highly improved.Frequent seizures occurred again in (b)(6) 2014, together with the onset of painful muscle spasms in the left face which coincided with stimulation pulses, the patient indicated that the spasms could be stopped by applying pressure on the neck, close to the lead implant area.The spasms had been previously noticed ten months after implantation and they resolved reducing the intensity of the stimulation.The medical professionals suspected a leakage of current due to the presence of increased seizures and muscle spasms.The generator had been implanted for ten years already and it was estimated that the battery would be approaching the end of life.Therefore it was decided to replace the whole vns system.The explanted lead was not kept as it was damaged during the explant.The pulse generator was disposed of by mistake.Programming and diagnostic history was reviewed and it confirmed that system diagnostics returned normal impedance results through (b)(6) 2012.Attempts to obtain further information have been unsuccessful to date.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the generator and the lead 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: 4877263
• MDR Text Key: 17580316
• Report Number: 1644487-2015-05057
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2006
• Device Model Number: 102
• Device Lot Number: 011040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2004
• 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: 47 YR