MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 05/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently did not include the udi.

Event Description

Analysis of the returned generator was completed.The battery voltage measured 2.722 volts (at ifi) during completion of the final electrical test.Bench testing indicated that the module was measuring the battery voltage correctly.Results of testing indicate that the battery voltage is at the low end of the specification.The cause of the low battery condition was not determined.Electrical test results showed that the pulse generator performed according to functional specifications.

Event Description

It was reported that during a generator replacement for the patient, a new generator still in the sterile packaging showed neos=yes upon interrogation.System diagnostics were run and then the generator was re-interrogated which again showed neos=yes.The generator was reportedly not stored in a cold environment and felt to be at room temperature.Thus, a new generator was implanted instead.Programming data for the generator on the attempted implant date was received.Analysis of the data showed that the battery voltage read 3.369v during final manufacture test on (b)(6) 2015.However, on the date of implant ((b)(6) 2015) the battery voltage measurement showed 2.414v upon interrogation and then 2.426v following the system diagnostics, both of which would display an neos=yes message.The programming data showed that the measured temperature during these interrogations were around 10.9 to 12.6 degrees celsius.The generator showing neos=yes was received for analysis.However, an analysis has not been completed to date.

Event Description

Additional analysis of the generator battery was performed externally by the battery manufacturer, and the results of testing were returned.The open circuit voltage, mid-cell thickness, impedance and microcalorimetry measurements were all consistent with a near beginning of life cell.The cathode separator was thoroughly inspected twice at magnifications between 10x and 63x.No defects were noted in the cell assembly.The internal glass-to-metal seal was also thoroughly inspected.The cell exhibited an acceptable pin to lid resistance value of 50 gohms.Additionally, the header assembly passed the leak testing.No defects were identified during the destructive analysis that would account for the low battery voltage observed by the vns manufacturer.

• Brand Name: PULSE GEN MODEL 104
• 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: 4842175
• MDR Text Key: 13970793
• Report Number: 1644487-2015-04875
• 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,company representative,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2015

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: Health Professional
• Device Expiration Date: 02/27/2017
• Device Model Number: 104
• Device Lot Number: 4315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/06/2015; 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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: 62 YR