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

Model Number 103

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the surgeon attempted to implant the m103 generator, but reported the device failed the lead test three times and failed with the test resistor in 3 times.The dhr for the generator was reviewed and found to have passed all testing prior to release.It was noted the device would be returned for analysis; however, the device has not been received by the manufacturer to date.It was also noted the patient would be scheduled again for implant surgery; however, no known surgeries have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported the patient was later successfully implanted on (b)(6) 2016.The complaint generator was received for analysis by the manufacturer.Analysis is expected, but has not been completed to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Product analysis for the returned generator was completed.The reported high impedance was not duplicated in the lab.Additionally, the ram/flash data downloaded from the generator shows no indication of increased impedance; the initial pre change value was 0 ohms and the post change value was 4035 ohms (the ohms value is within normal limits), with the date of occurrence on (b)(6) 2016 (the date of implant was (b)(6) 2016).Various electrical loads were attached to the generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the generator.

Event Description

Additional programming information was received from the site and reviewed.No anomalies were noted and the only data available was from the date of surgery.No anomalies were noted and no diagnostic information was available within the data.The data received was then decoded for further review.The decoded date revealed that no diagnostic tests had been performed and the lead impedance observed by the physician was the random stored value that is stored in the generator after the final electrical test, prior to distribution.This value is random and is wiped by performing a diagnostic test.Since there was not a diagnostic test performed, the random stored value was observed as high impedance.The decoded data also shoed 3.290 volts and showed that only 0.133% of the battery had been depleted to date.After a little over an hour of the device being programmed on and several interrogations had been performed, the data showed the battery had depleted to 0.134% and the voltage remained the same.There was no indication that an issue with the device was present.

• Brand Name: PULSE GEN MODEL 103
• 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: 5965701
• MDR Text Key: 55671880
• Report Number: 1644487-2016-02143
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2017

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: 04/02/2017
• Device Model Number: 103
• Device Lot Number: 203374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2016; 10/21/2016; 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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: 12 YR