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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNK

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CYBERONICS, INC. LEAD MODEL UNK Back to Search Results
Event Date 02/27/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. The generator was programmed off and the patient was referred for x-rays. The patient may be referred for surgery. No known surgical intervention has been performed to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

The previously submitted mdr inadvertently provided the wrong evaluation codes.

 
Event Description

It was reported that through the programming history database periodic review high impedance occurred on vns patient's generator model 102 serial number (b)(4).

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.

 
Event Description

X-rays dated on (b)(6) 2015 were provided to the manufacturer for further review. The generator appears in the right chest in an abnormal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.

 
Manufacturer Narrative

The previously submitted mdr inadvertently provided an incorrect gender. The previously submitted mdr inadvertently provided an incorrect event date. The previously submitted mdr inadvertently provided an incorrect event description. The previously submitted mdr inadvertently provided an incorrect data.

 
Event Description

The available programming history data of the patient¿s device (model 102 sn (b)(4)) was reviewed. The data was observed from (b)(6) 2013 through (b)(6) 2014. The device was last programmed on (b)(6) 2014 to 8% duty cycle. The last parameters recorded were 0 ma/20hz/250¿s/21sec/5min and magnet mode was1. 25 ma/21sec/250¿s. Diagnostic data was also found. Last diagnostic recorded was on (b)(6) 2014. The lead impedance was high (dcdc 7) and eri no. The parameters data also indicated that the stimulation ok. The review of the available programming history revealed high impedance observed on (b)(6) 2014.

 
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Brand NameLEAD MODEL UNK
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
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 Key4427254
Report Number1644487-2015-03645
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/30/2016
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

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