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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 Problem High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2016
Event Type  malfunction  
Event Description
It was reported that a patient was referred for full revision surgery due to high impedance.The physician reported that x-rays showed a lead fracture on (b)(6) 2016.The cause of the high impedance/lead fracture was unknown.The patient had full revision surgery on (b)(6) 2016.The explanted generator and lead were received on 08/23/2016.The generator evaluation will be reported in mfr.Report #1644487-2016-01943 for possible premature battery depletion.Analysis of the lead has not been approved to date.
 
Event Description
Analysis of the lead was approved on 09/02/2016.Note that a portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.Multiple breaks were identified in the quadfilar coil, and extensive pitting was present.The pitting prevented identification of the coil fracture type of one of the breaks.Another break was identified to be due to mechanical damaged with pitting, and it was believed that stimulation was present for a certain period of time.The abraded openings found on the outer silicone tubing, connector ring inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and connector ring inner silicone tubing.With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
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Brand Name
LEAD MODEL 302
Type of Device
LEAD
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 Key5909500
MDR Text Key54064599
Report Number1644487-2016-01942
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2010
Device Model Number302-20
Device Lot Number200485
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2016
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 08/02/2016
Initial Date FDA Received08/27/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age12 YR
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