MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems High impedance (1291); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

It was reported by the tc that during a prophylactic generator replacement, two separate model 106 generators showed high impedance and pin insertion difficulties.This report captures the first generator's high impedance and pin insertion difficulties, and mfr.Report # 1644487-2017-05097 captures the second generator's high impedance and pin insertion and removal difficulties.Reportedly, the surgeon connected the first model 106 and system diagnostics found high impedance.The lead was re-inserted, and the surgeon visually confirmed that the lead tip was past the connector block.He also confirmed that the set screw was fully tightened down.However, system diagnostics detected high impedance again.The surgeon then inserted the test resistor and performed generator diagnostics.Generator diagnostics also detected high impedance.The surgeon then reconnected the lead to the old 103 generator.System diagnostics on the old 103 generator were within normal limits.The surgeon then tried a second model 106 generator and experienced the same high impedance issue.The same troubleshooting used for the first generator were applied, but high impedance was still detected through both system diagnostics on the lead and generator diagnostics with the test resistor.The surgeon also reported that the lead didn't fit into the generators correctly; he had pin insertion difficulties with both generators and pin removal difficulties with the second generator.The surgeon said that he had released the air pressure with the screw, but this did not resolve the issue.A new model 103 generator was used and the issue resolved.The doctor looked at the openings of both the 103 and 106 and saw no difference.The manufacturer's device history records were reviewed; all of the generator's quality specifications were passed prior to distribution.The suspect product was received, but product analysis has not been completed on the generator to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generators.Product analysis on the first generator (captured in the current mft.Report) was unable to duplicate either high impedance or pin insertion difficulties.With regards to the allegation of high impedance, various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.With regards to the insertion difficulties, no obstructions were observed in the header lead cavity or in the connector block.A bench lead was able to be completely inserted into the generator.In addition, the returned set screw bottom showed indention marks, indicating that a lead pin or in-line test resistor was at one time secured by the returned set screw.Product analysis on the second generator (captured in mfr.Report # 1644487-2017-05097) was unable to duplicate either high impedance or pin insertion difficulties.With regards to the allegation of high impedance, various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.With regards to the insertion difficulties, no obstructions were observed in the header lead cavity or in the connector block.A bench lead was able to be completely inserted into the generator.Appropriate retention force was demonstrated the manufacturer's programming history database showed that system diagnostics were only performed twice on each generator on the date of surgery.No generator diagnostics were performed as originally reported.The manufacturer's device history records of the lead were reviewed.The lead passed final quality and functional tests prior to release.No further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem.Corrected data: the following statement was inadvertently omitted from the supplemental mdr 1 "product analysis on the second generator (captured in mfr.Report # 1644487-2017-05097) also found that the returned set screw bottom showed indention marks, indicating that a lead pin or in-line test resistor was at one time secured by the returned set screw.".

Event Description

The company representative reported that he had seen the high impedance messages on his interrogation screen.No further relevant information has been received to date.Product analysis on the second generator (captured in mfr.Report # 1644487-2017-05097) also found that the returned set screw bottom showed indention marks, indicating that a lead pin or in-line test resistor was at one time secured by the returned set screw.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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 Key: 7156367
• MDR Text Key: 96116481
• Report Number: 1644487-2017-05098
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient 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: 04/29/2019
• Device Model Number: 106
• Device Lot Number: 5308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/31/2017
• Supplement Dates Manufacturer Received: 01/22/2018; 02/22/2018
• Supplement Dates FDA Received: 02/19/2018; 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR