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

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.

• 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 Key: 3589007
• MDR Text Key: 4333917
• Report Number: 1644487-2014-00292
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• 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 Date: 06/30/2013
• Device Model Number: 103
• Device Lot Number: 3067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 01/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2014; 05/07/2014; 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial