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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 11/11/2010
Event Type  Injury  
Event Description

Additional information was received on (b)(6) 2011 when clinic notes from the patient's physician were received. In the clinic notes dated (b)(6) 2011, the patient reported that not only had the generator become infected, but the lead also became infected and he had to have the lead explanted as well and go on more antibiotics. He reported that the infection was a (b)(6). Since the explant he reported that he has been having some dizziness and is unstable with ringing in his ears and dots in his vision and sometimes feel like he is going to black out. He also reports pain under his left axilla that goes down across his chest and stomach. Clinic notes dated (b)(6) 2011 revealed that the patient wants a vns re-implanted. Although surgery is likely, it has not yet occurred. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

Event Description

Additional information was received on (b)(6) 2011 when the manufactures consultant reported that the patient had a neck exploration surgery that day to determine whether or not the patient would be reimplanted with vns. The surgeon decided not to implant a new vns system as he found that the vagus nerve was adhered with scar tissue to the internal jugular. The surgeon stated that he did not think it was possible to dissect the vagus from the internal jugular without damaging the internal jugular.

Event Description

On (b)(6) 2011, additional information was received when the physician's assistant reported that the lead infection was first noticed on (b)(6) 2010 when the patient's family noticed a knot on the left side of neck and chest. The patient was told to go to the hospital for evaluation and the lead was removed around (b)(6) 2011. The patient was given iv antibiotics. The patient's family reported that the patient had had (b)(6). No patient manipulation or trauma had occurred that was believed to have caused or contributed to the infection. The physician's assistant did not know if it was the same infection as the infection at the generator site. He also was not aware that the patient was having any pain but said that it was probably related to the surgery and infection.

Event Description

Reporter indicated that his vns generator was explanted due to infection at the generator site in the chest, and the vns lead was left intact. The pt is currently on antibiotics for the infection. All attempts to the treating surgeon for further info have been unsuccessful to date.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of the manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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Manufacturer (Section D)
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key1943766
Report Number1644487-2010-02927
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup,Followup,Followup
Report Date 12/14/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device EXPIRATION Date12/31/2011
Device MODEL Number102
Device LOT Number2701
Was Device Available For Evaluation? No
Date Manufacturer Received11/30/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 12/29/2010 Patient Sequence Number: 1