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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 11/01/2010
Event Type  Injury  
Event Description

It was reported by a company representative that a vns patient indicated her device was not working a couple of weeks after being implanted on (b)(6) 2010. The patient additionally reported her device had migrated under her armpit and reported she could no longer feel stimulation (unknown start date). The patient indicated that the device was working on (b)(6), and she would have voice alterations with stimulation. However, the patient stated that "one morning she woke up and noticed her device had moved". Over the next couple of days, she then noticed her voice no longer changed with stimulation and even tried using the magnet, but was unable to feel stimulation. Additional information was received through a company representative indicating the patient saw her treating physician and her device was working well on (b)(6) 2010. The treating nurse evaluated the patient and did not appear to be concerned with the patient's events, however, the patient was scheduled to see her treating neurologist. Further information from a company representative revealed the patient's device was fine and was scheduled to have vns repositioned.

 
Event Description

Clinic notes reiceed reported that the patient had generator repositioning surgery on (b)(6) 2010. On (b)(6) 2014, system diagnostics were within normal limits with impedance value of 2826 ohms.

 
Manufacturer Narrative

Date of this report, corrected data: the initial report inadvertently reported this data incorrectly. The initial aware date was (b)(6) 2010. Suspect medical device lot #, corrected data: the initial report inadvertently did not report this data. Date received by manufacturer, corrected data: the initial report inadvertently reported this data incorrectly. The initial aware date was (b)(6) 2010.

 
Event Description

It was reported that it is believed that a non-absorbable suture was used to secure the generator to the fascia during implant.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
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 Key1936653
Report Number1644487-2010-02844
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2011
Device MODEL Number103
Device LOT Number2617
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2010
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: 12/17/2010 Patient Sequence Number: 1
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