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

Model Number 103

Device Problems Premature Discharge of Battery (1057); Battery Problem: High Impedance (2947)

Patient Problem No Code Available (3191)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient's generator seemed to be depleting more quickly than expected, because her battery status icon was showing about 75% of the battery depleted only 10 days after implant.Programming data was received on (b)(6) 2015, and there was evidence of beginning of life high battery impedance that may have drained the battery more quickly than expected in the first 10% of battery life.More programming data was received on (b)(6) 2015, which indicated that the battery voltage was rebounding after the first 10% of the battery life.However, it is unknown if the high settings may have prevented the battery from rebounding to a higher voltage.The investigation determined that the battery voltage behavior was likely related to an increased duration of the high battery impedance experienced by cfx batteries during the beginning of life or an internal short that managed to "burn" itself out.

Event Description

The patient was referred for generator replacement due to battery depletion on (b)(6) 2016.It was clarified that the device was pulse disabled upon interrogation.The patient had generator replacement surgery on (b)(6) 2016.The generator was discarded, so no analysis could be performed.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #1 inadvertently left off relevant information regarding the event.

Event Description

The data from the generator over the time it was implanted suggests that the battery did deplete at the expected rate for the settings that the device was programmed to.There is no indication that there was beginning of life high impedance based on the information received.

• 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: 5312724
• MDR Text Key: 34671686
• Report Number: 1644487-2015-06798
• 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: 11/23/2015

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: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 4322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2016; 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• 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: 56 YR