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

Model Number 103

Device Problems Low Readings (2460); Communication or Transmission Problem (2896)

Patient Problem Unspecified Infection (1930)

Event Date 08/22/2016

Event Type  Malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a physician could not interrogate a vns patient's device on (b)(6) 2016. It was reported that the day before, on (b)(6) 2016, the patient underwent surgery due to infection where the wound was cleaned without explanting the device (event reported in the medwatch report 1644487-2016-02050). Before the surgery, the device was switched off without any issues. The physician did not perform a diagnostics test, but there was no issue with the patient's generator. After the surgery, when the physician tried to switch the device back on (on (b)(6) 2016), communication issues occurred. The physician tried many times before she could finally interrogate the generator. It then stated that the generator was at end of service. The device was implanted in (b)(6) 2016 (2 months ago). Diagnostics test showed: low output current, impedance ok, 2806 ohm, eos yes. It was reported that another physician came to help using her programming system, but she could never communicate with the device. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Further information from the physician indicated that, 10 days after the surgery they still could not interrogate the patient's generator. As the infection was still there, it was decided to explant the device. It was reported that the patient underwent explant surgery on (b)(6) 2016. The return of the explanted device is expected but it has not been received to date.

Event Description

Further information from the surgeon was received indicating that during the surgery, an equipment could have touched the device, which could have caused the premature end of service. The explanted generator was returned to the manufacturer on 10/31/2016. Analysis is underway but it has not been completed to date.

Event Description

Analysis of the returned generator was completed. It indicated that the reported allegation of ¿asic latch-up condition¿, could be verified in the pa laboratory. Review of the data downloaded from the pulse generator indicated that the pulsedisabled byte was set to a value that represents a vbat

• 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: 5948700
• MDR Text Key: 55039436
• Report Number: 1644487-2016-02051
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (Y/N): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/14/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 03/31/2017
• Device MODEL Number: 103
• Device LOT Number: 300312
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial