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

Model Number 103

Device Problems Energy Output To Patient Tissue Incorrect (1209); Impedance Problem (2950)

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

Event Date 10/04/2016

Event Type  malfunction  

Event Description

The physician reported that the patient may have bad lead impedance.In clinic notes, he noted that the diagnostics were concerning for lead impedance.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: the following statement was inadvertently not added to the initial mdr "no known surgical intervention has occurred to date.".

Event Description

It was reported that the patient's generator was replaced.The impedance on the new generator was within normal limits.System diagnostics indicated that the patient's previous generator had a low output current and that the patient's battery intensive follow up indicator had been triggered.The generator's impedance was within normal limits.Although the battery indicator was flagged, the patient should have been receiving their intended therapy.Ohm's law calculations determined that the patient's explanted generator should have been able to provide at least 3.25 ma of output current.Per system diagnostics, the patient's generator was only able to provide 2.75 ma of current.The generator's internal data was reviewed and a low output current was verified.The generator was programmed to deliver 3 ma; however, the last output current delivered was 2.75 ma.No other anomalies were noted.The device history records were reviewed, and it was verified that the device passed its final functional test and quality inspection.The patient's generator was reportedly discarded.No further relevant information has been received to date.

Manufacturer Narrative

The data regarding the "last >= 25% change in impedance" on (b)(6) 2015 was inadvertently not completed on supplemental mdr report 1.This line of data should have read "(b)(6) 2015: last >= 25% change in impedance: 2520 ohms to 3182 ohms.".

• 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: 6141276
• MDR Text Key: 61609495
• Report Number: 1644487-2016-02762
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 02/10/2017

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: 05/31/2015
• Device Model Number: 103
• Device Lot Number: 202509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/07/2017; 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2013
• 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: 46 YR