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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 07/02/2012
Event Type  Malfunction  
Event Description

The implant card reports that the patietn had generator and lead replacement surgery on (b)(6) 2013 due to lead discontinuity.

Event Description

Supplemental report 01 reported that setscrew marks were observed near the end of the connector pin, indicating the lead had not been fully inserted into the cavity of the generator. Additional review of the product analysis results shows that the connector pin was reinserted into the cavity of the a model 103 pulse generator (since the original generator was not available) to verify an obstruction wasn¿t preventing the connector pin from being fully inserted. No obstructions were noted. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring.

Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr inadvertently omitted additional clarification from the product analysis results.

Event Description

It was initially reported on (b)(6) 2013 that the patient was scheduled for vns replacement surgery on (b)(6) 2013, but the reason was unknown. An implant card was later received from the company representative indicating that the patient had generator and lead replacement surgery on (b)(6) 2013 with the reason marked as ¿lead discontinuity. ¿ lead impedance following replacement surgery was within normal limits. Review of the manufacturer¿s available diagnostic history of the device shows high lead impedance was present on the date of implant but resolved via intraoperative replacement/troubleshooting. The patient¿s lead was replaced on (b)(6) 2009 as previously reported in mfg report #: 1644487-2009-01787. System diagnostics following full revision surgery on this date resulted in okay results, indicating proper device function. The last available diagnostics on (b)(6) 2012 also indicate the device was functioning as intended at that time. Follow up with the treating physician¿s office revealed that the patient and caregiver came in to the clinic on (b)(6) 2013 due to the patient¿s increased seizure activity and the magnet appearing to not abort seizure activity so the caregiver was concerned. The device was found to be at end of service condition. ¿the patient's magnet and output current being delivered was noted as 0ma but should be 3. 0ma and 3. 5ma. " it was reported that there was no current delivery from the generator, so the patient was not receiving the intended therapy. The caregiver reported the increased seizures began in the early spring of 2013, and the physician¿s office attributes it to ¿no therapeutic vns settings. ¿ the patient¿s anti-seizure medications remained the same during this time. The patient¿s best seizure control was after corpus callosotomy and vns therapy between 2010 and 2012, per the caregiver. No interventions were taken for the increased seizures as the family refused more medication. There were no recent changes anti-seizure medications before the onset; it was noticed once the vns ¿had no current delivered¿ due to end of service. No x-rays were taken prior to surgery. The patient was last seen on (b)(6) 2012. Per the physician¿s notes, the mother thought the seizures were increased, so the physician increased medication. Clarification was received indicating the device was at end of service condition at eos=yes where the device is at a pulse-disabled state and therefore not delivering therapy. The patient was referred for generator replacement due to end of service of the generator. No high impedance was detected by the treating physician¿s office. Therefore, the device was not intentionally programmed off prior to replacement. There was no patient manipulation or trauma was reported. The explanted generator and lead were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date. The return product form indicated the reason for replacement was ¿lead discontinuity. ¿.

Manufacturer Narrative

Review of device history records. Review of the lead device history records confirmed all quality tests were passed prior to distribution.

Event Description

Upon further follow-up by the physician¿s assistant, it was reported the increased seizures in (b)(6) 2012 were not related to vns. No programing changes were made at that time, and diagnostics were within normal limits. Product analysis for the generator confirmed the end of service of the battery. An end-of-service warning message was verified in the pa lab and found to be associated with the pulsedisabled by the pulse generator. Therefore, providing evidence that the depleted battery may have been a contributing factor to the increased seizures as reported. Further review revealed that the explanted generator was returned with the output current programmed to 3. 00 ma. The data from the internal memory of the generator shows a impedance of 6357 ohms (previous recorded impedance value was 4814 ohms), estimated occurrence on (b)(6) 2012. The vns programming history database shows the last known diagnostic data was on (b)(6) 2012, lead impedance was 1014 ohms. The combination of a high impedance value and output current setting required a ¿vboost¿ compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v). This condition contributes to the disparity between the end of service condition and % battery capacity that has been consumed, based on the device¿s internal end of service projection system. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. Other than the noted conditions, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the generator device history records confirmed that all quality tests were passed prior to distribution. Analysis of the lead was also completed on the returned portion of the lead. During the visual analysis, multiple quadfilar coils appeared to be broken with areas of extensive pitting which prevented identification of all coil fracture types. Broken coil strands had evidence of stress induced fracture (torsional appearance) which most likely completed the fracture with mechanical damage and pitting, in addition to mechanical damage, secondary break lines, stress marks, and residual material. Pitting was observed on the coil surface along coil break. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. During the visual analysis a large portion of the lead assembly appeared to be compressed and twisted. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. 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 except for the setscrew marks observed near the end of the connector pin, indicating the lead had not been fully inserted into the cavity of the generator. No other sets of setscrew marks were observed on the connector pin.

Manufacturer Narrative

Device failure occurred and may have contributed to the increased seizures.

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
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 Key3194576
Report Number1644487-2013-01960
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/04/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/27/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number304-20
Device LOT Number2440
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/10/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/22/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial