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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
Event Date 08/21/2014
Event Type  Injury  
Event Description

It was reported that the patient underwent an incision and drainage of a left scapular abcess and complete removal of the vns system. Both lead and generator were explanted. The explanted devices were returned for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

Analysis of the lead was completed on 09/22/2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Mfr. Report # 1644487-2014-02711 will house the lead analysis. Analysis of the generator was completed on 09/25/2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

 
Event Description

Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The adverse events reported here appear to be the result of the lead malfunction reported in mfr report #1644487-2014-02711.

 
Manufacturer Narrative

Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
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 Key4103311
Report Number1644487-2014-02414
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/22/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2009
Device MODEL Number302-20
Device LOT Number1598
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/30/2006
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: 09/19/2014 Patient Sequence Number: 1
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