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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Break; High impedance
Event Date 09/24/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported on (b)(6) 2015 from the patient's mother that the patient was seen on (b)(6) 2015 and the physician indicated that the device wires are either disconnected or broken. The sales representative was able to see the patient on (b)(6) 2015 right after the report and interrogated the device and found that she did have high impedance >10,000 ohms. Upon examination of the x-rays it appeared that the pin was not past the connector block. She noted that the x-rays were very large and the only copy and she was not allowed to obtain a copy. The physician plans to revise as soon as possible. Although surgery is likely it has not occurred to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported in (b)(6) 2015 that the patient was in surgery and the lead pin was reinserted but this did not resolve the high impedance issue. The patient is scheduled for lead replacement although this has not occurred to date.

 
Event Description

It was reported that the surgeon never opened the patient's neck to visualize the lead. He stated that there was too much scarring and he didn¿t have time to revise the lead. It was assumed that the lead would be scarred in during the next replacement. The surgeon decided that he wants to do a right sided implant a next times a result of the incision scarring. It was reported on 01/19/2016 that the patient¿s neurosurgeon is referring her to an ent to assess right and left side paralysis of the vocal cords. The neurosurgeon¿s plan is to re-implant the vns on the right side. The relationship of the vocal cord paralysis and high impedance is unknown.

 
Event Description

The patient still has not seen the ent to evaluate the vocal cord paralysis, therefore at this time there is no confirmation of the reported vocal cord paralysis. The physician wants the ent to evaluate the right side for vocal cord paralysis since he wants to put the electrodes on the right side.

 
Event Description

Patient underwent full revision surgery on (b)(6) 2016 due to high impedance. The explanted devices were discarded due to hospital policy.

 
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Brand NameLEAD MODEL 302
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 Key5162668
Report Number1644487-2015-06181
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 09/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1334
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2005
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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