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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Event Date 12/12/2012
Event Type  malfunction  
Event Description
The physician reported that he may not refer the patient for replacement and may just leave the device off; however, the plan was unclear.It was later reported that the surgeon reported that he would correct the patient's lead and that the generator would be replaced also if need be.Surgery is planned, but has not occurred to date.
 
Event Description
Analysis of the generator was completed on (b)(6) 2014.Electrical test results showed that the pulse generator performed according to functional specification.Visual inspection results revealed no external device abnormalities.There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
A review of programming and diagnostic data was performed which identified a high impedance event.The high impedance was observed on (b)(6) 2012.Follow up with the nurse found that the high impedance was observed the same day the patient's generator was being replaced due to a depleted battery.The lead was not replaced.The patient was implanted with a new generator and diagnostics were all fine.Additional information from the physician found that the high impedance was initially seen as 10,000 ohms.Diagnostics two weeks after surgery showed an impedance value of 5,000 ohms, and then 10,000 ohms months later.The physician stated that before the high impedance was observed, the patient did fall.It was confirmed that the high impedance was initially observed during surgery.Ap and lateral chest and neck x-rays were taken and sent to the manufacturer for review.The generator was seen in the left chest.The filter feedthru wires were intact.The connector pin inside the connector block does not appear to be completely inserted.The lead wire was intact at the location of the connector pin.There did not appear to be any lead discontinuities or sharp bends, however there was a portion of the lead located behind the generator that could not be assessed.The electrode placement was not done as per labeling as the electrode placement is inverted.There appeared to be no propper strain relief bend or loop per labeling.There were two tie downs present, but they did not appear to be placed per labeling to secure the strain relief bend.No additional information has been provided.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device.Device manufacturing records and programming history were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.X-rays reviewed by the manufacturer, no gross lead discontinuities visualized; however, lead pin not fully inserted past the connector block.Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
New information received corrects the suspect device.
 
Event Description
The patient underwent generator and lead replacement on (b)(6) 2014.It was reported that the generator was replaced prophylactically and that the high impedance was likely attributed to the lead pin not being fully inserted into the generator header.The generator and lead were returned for analysis.Analysis of the lead was completed on 05/06/2014.During the visual analysis a half set of setscrew marks was found at the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time.The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead.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.During the visual analysis what appeared to be pitting was observed on the surface of the connector ring.Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector ring.Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the connector ring pit deposit and identified the area as consisting of silicon, potassium, chromium, iron, nickel, sodium, manganese, fluorine and molybdenum.A definite cause for the pitting could not be determined based on the lead portion returned.However, a review of the patient x-rays' issue file correspondence suggest the electrodes may not have been attached to the nerve as intended.Other than observed pitting on the connector ring surface, no other obvious anomalies were noted except for the half set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.The additional 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 portion were performed, during the visual analysis, and no discontinuities were identified.There is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegations of 'hgh impedance'.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Analysis of the generator is underway, but has not been completed to date.N.
 
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Brand Name
PULSE GEN MODEL 103
Type of Device
GENERATOR
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 Key3589007
MDR Text Key4333917
Report Number1644487-2014-00292
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/30/2013
1 Device 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 Date06/30/2013
Device Model Number103
Device Lot Number3067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2014
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 05/14/2014
Initial Date FDA Received01/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received03/31/2014
05/07/2014
06/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
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