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

Model Number 106

Device Problem High impedance (1291)

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

Event Date 12/01/2016

Event Type  malfunction  

Event Description

It was reported via clinic notes that an impedance value of >10000 ohms was observed on a patient's device.The patient's settings were decreased due to the high impedance, causing the patient to experience an increase in seizures.The patient was not known to have experienced any trauma.X-rays of the device were not ordered at either the patient's clinic visit or the surgical consult.No additional relevant information has been provided to date.No surgical intervention has occurred to date.

Event Description

The patient underwent full revision surgery.The explanted lead and generator have been returned to the manufacturer, but analysis for the explanted devices has not been approved to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the returned generator.When received, the programming data was downloaded from the generator and reviewed.High impedance was first observed 4 months after implant and occurred intermittently through the remainder of the implant time of the device.Visual examination of the generator did not identify any abnormalities with the external part of the generator.The generator was interrogated, and system diagnostic tests were performed and returned results within the normal limits.Electrical evaluation showed that the device performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.Analysis was approved for the returned lead.The lead body was returned in one portion.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.Set screw marks were observed towards the end of the connector pin, indicating the connector pin had not been fully inserted into the generator.No other sets of set screw marks were observed.Canted spring indentations were also observed on the rear end of the small front o-ring, indicating insufficient mechanical contact between the generator and connector ring.The position of the set screw marks and canted spring indentations indicate that there may have been a suspect electrical connection to the lead.No discontinuities were identified during the continuity check of the lead.There was no evidence to suggest an anomaly with the returned portion of the lead.Incomplete insertion of the connector pin may have been a potential cause for the observed high impedance condition.No additional relevant information has been provided to date.

• 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: 6578874
• MDR Text Key: 75609729
• Report Number: 1644487-2017-03843
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2017
• Device Model Number: 106
• Device Lot Number: 203824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 06/22/2017; 07/27/2017
• Supplement Dates FDA Received: 07/19/2017; 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 37 YR