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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Device Problem Malposition of device
Event Date 01/03/2011
Event Type  Injury  
Event Description

It was reported by a company representative that a vns pt was scheduled to undergo repositioning of the generator. The pt had recently undergone vns re-implant surgery on (b)(6) 2010 and now was scheduled to have generator repositioning due to discomfort from the present generator positioning. Further info was received from a company representative indicating the pt had cancelled her surgery due laboratory abnormalities, including a high ammonia level per pt that caused procedure to be postponed. At the moment, no appointment has been scheduled. Good faith attempts to obtain additional info from the treating neurologist have been unsuccessful to date.

 
Event Description

On (b)(6) 2011 additional information was received when the physician reported that he referred the patient to a surgeon for repositioning of the generator. The surgery took place on (b)(6) 2011. The generator was repositioned along with the lead body; the lead on the nerve was not adjusted. The device was interrogated and system diagnostics showed results within normal limits with a dcdc code of 2 and lead impedance showing ok. The patient's generator was let at previous settings.

 
Event Description

Operative notes were received from the (b)(6) 2011 repositioning surgery. The patient had indicated that she had been unhappy with the location of the generator as the lead was too tight and the battery was too close to her clavicle and shoulder. The note indicated that the lead was coiled up in scar tissue from the previous vns battery underneath the pocket of the old battery. Once the surgeon freed the lead up, there was plenty of loose lead in the subclavicular region; however, it was still a bit tight in the neck. Therefore, he opened the neck incision, cut and removed one of the tie-downs and then cut the second tie-down and lowered it inferiorly, anchored that one to the sternocleidomastoid muscle but in a lower area which freed up more of the lead in the neck region. He then created a new pocket for the generator. Post-operative diagnosis was neck pain from the vns lead.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
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 Key1975979
Report Number1644487-2011-00137
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/27/2011 Patient Sequence Number: 1
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