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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Appropriate Term/Code Not Available
Event Date 04/01/2015
Event Type  Malfunction  
Manufacturer Narrative

Event Description

It was reported that the vns patient was feeling of sporadic and painful stimulation. It was reported that patient seizures are well controlled and patient has been seen a huge improvement with the vns therapy. It was reported that patient underwent generator replacement for prophylactic reason (b)(6) 2015 and the adverse events persist. The explanted generator was reported as disposed of by the hospital and will not be returned to the manufacturer. Further information was received that the intense stimulation continues with the new generator. It was also reported that patient had increase in seizures; the current seizure rate is above pre-vns levels. It was reported that the medical professional suspects a problem with the lead such as current leakage which may not appear on the diagnostic test, therefore evoked potential test in various positions will be performed. It was reported that regardless of outcome evoked potential outcome, lead revision is expected. No known surgical interventions have occurred to date.

Manufacturer Narrative

Age at time of event and date of birth; corrected data: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth.

Event Description

Further information was received from the physician, indicating that a new diagnostic test was performed and returned impedance results within normal limits with 1344 ohms. An emg-based lead test was also performed which resulted to be normal. It was reported by the physician that, despite these results, they decided to replace both the lead and the generator (since the lead is 18 year old). No known surgical intervention has occur to date.

Event Description

An implant card received by the manufacturer and the review indicates that the vns patient underwent full revision surgery on (b)(6) 2016 and that the re-implant was due to lead break. The lead impedance for the new implant was marked as ok - 1486 ohms. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description

A return good authorization number request was received by the manufacturer to return the explanted generator model 104 serial number (b)(4) implanted with the suspect device involved in the present case. Return of the generator for analysis is expected, but it has not been received to date.

Event Description

Portion of the suspect lead was received by the manufacturer. The explanted generator was received as well. It was reported that the reason for replacement is patient experiencing stimulation more than expected: side effect of a leak of electricity. Analysis of the suspect lead was completed and the allegations were not verified within the returned lead portions. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Review of manufacturing records confirmed all tests passed for the lead prior to distribution.

Event Description

Analysis was completed on the explanted generator and reported allegation of "high impedance" was not duplicated. Review of the data downloaded from the generator shows a possible indication of increased impedance from a value of 1305 ohms, to a value of 22812 ohms, and the time of change detection was (b)(6) 2016 (generator explant on (b)(6) 2016). The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2015 with an impedance value of 1357 ohms (implant (b)(6) 2015 / explant (b)(6) 2016). Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, the battery status was ifi no. The data in the "diagaccumconsumed" memory locations revealed that 16. 488% of the battery had been consumed.

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key5229194
Report Number1644487-2015-06473
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup,Followup
Report Date 10/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/1998
Device MODEL Number300-20
Device LOT Number3058C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/23/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/17/1996
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial