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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
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.

 
Manufacturer Narrative

 
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.

 
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Brand NamePULSE GEN MODEL 101
Type of DeviceGENERATOR
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 Key3606821
Report Number1644487-2014-00350
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
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 Received02/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2002
Device MODEL Number101
Device LOT Number2837
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/30/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2001
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/04/2014 Patient Sequence Number: 1
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