MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Erythema (1840)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Notes dated (b)(6) 2013 indicated that the patient may have had a seizure on (b)(6) 2013.The device was interrogated at 1.75/20/130/30/5/1.75/30.The impedance was ok (dcdc=3), the output status was ok, and the battery was noted to be functioning well.Notes dated (b)(6) 2013 indicated that the patient presented with a 2 year history of voice changes and hoarseness.The patient did not experienced any hoarseness following vns implant, except when it fires.A flexible videostroboscopy was performed with mild atrophy and supraglottic contraction but otherwise normal results.The event was determined to be muscle tension dysphonia for which the patient was referred for speech therapy.Clinic notes dated (b)(6) 2013 stated that the patient felt that her device was no longer working.The patient had three grandma seizures during the year.Prior to that, the patient had not had any seizures in 12 years.The patient also noted that her voice felt weak at times and thought the events might be related.A flexible laryngoscopy was performed: bot, vallecula, and piriform sinuses were clear and normal.Both true vocal cords showed good mobility, but there was possible slight bowing with a 1 mm gap.Moderate arytenoid erythema and mild edema were present.It was reported that the patient has possible mild age related atrophy and mild laryngitis contributing to her voice changes.The patient was referred for generator revision.The vns generator replacement was performed on (b)(6) 2014.The explanted vns device was discarded and therefore cannot be returned.Attempts are being made for additional information; however, no other information has been provided.

Event Description

It was reported that the generator battery was dying and the patient experienced more seizures.The physician reported that the patient is doing much better since generator replacement.

• Brand Name: PULSE GEN MODEL 101
• 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: 3606821
• MDR Text Key: 15156684
• Report Number: 1644487-2014-00350
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2002
• Device Model Number: 101
• Device Lot Number: 2837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2001
• 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): Other
• Patient Age: 64 YR