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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem High impedance (1291)
Patient Problem Seizures (2063)
Event Date 07/31/2015
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
It was reported by the physician that high impedance was observed on the patient's vns device during an office visit on (b)(6) 2015.It was also reported the patient began experiencing an increase in seizures at the end of (b)(6).It was stated the physician believes the recent increase in seizures is due to the high impedance observed.It was noted the physician will keep the device programmed on for now.No known surgical interventions have occurred to date.
 
Event Description
It was reported the patient's surgery was scheduled for (b)(6) 2015.The replacement surgery was completed on (b)(6) 2015.It was reported the physician believed the anchor tether came off the nerve and he elected to replace the lead.The vns generator was replaced prophylactically.Both the vns generator and the lead received by the manufacturer.Product analysis is expected but has not been completed to date.No additional relevant information has been received to date.
 
Manufacturer Narrative
If explanted, give date; corrected data: this information was inadvertently left off of supplemental #01 mfr.Report.Device available for evaluation; corrected data: this information was inadvertently left off of supplemental #01 mfr.Report.
 
Event Description
Product analysis for the returned generator was completed.The end of service warning message was verified and found to be associated with the output being disabled by the vns generator, burn marks were observed on the vns generator which indicated the generator may have been exposed to electro-cautery during explant.The vns generator was reset in order to allow for subsequent testing.It was found using the downloaded data from the generator that the date of the impedance increase was 05/04/2015.Electrical tests were performed on the vns generator and the results demonstrate that accurate resistance measurements were obtained in all instances.The device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the vns generator current for the entire monitoring period.The electrical evaluation showed that the vns generator performed according to functional specifications.Product analysis for the returned lead was completed.It should be noted the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.Visual analysis showed a portion of the lead assembly appeared to be twisted and knotted together.These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler).The abraded opening found on the outer silicone tubing and the cut ends that were made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the observed inner remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process.
 
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Brand Name
LEAD MODEL 304
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 Key5113453
MDR Text Key27254391
Report Number1644487-2015-05969
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 Physician
Type of Report Followup
Report Date 09/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2016
Device Model Number304-20
Device Lot Number3322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2015
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/30/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2012
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 Outcome(s) Required Intervention;
Patient Age15 YR
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