MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Assigned udi: (b)(4).

Event Description

Information was received from the surgeon's representative.The patient had their old lead removed and a new lead implanted on (b)(6) 2016.The caller then noted that the new lead was not working with the patient's generator, so the patient's generator was replaced.It is unclear how the lead was not working with the generator.Additional information from the surgeon was received via fax stating that the generator was a "faulted generator".The explanted generator and lead were received on 12/09/2016.Analysis is underway, but hasn't been completed to date.Attempts at additional information have been made, but no additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: reference mfr report # 1644487-2016-02612 reports the allegation on the lead.Previous initial mdr inadvertently did not include the reference mfr report # for the allegation on the lead.(b)(4).

Event Description

Per company representative who was at the explant surgery, system diagnostic and interrogation were performed on the generator at the explant surgery which found the high lead impedance.However, no troubleshooting was performed.Decoder data from the tablet used during the explant surgery shows that the generator was only interrogated and programmed.No system diagnostics were documented to have occurred at the time of explant for this generator.As the system diagnostic test was not performed, the previously stored high impedance was not cleared.Per review of device history records , no unresolved non conformances were found on the generator and the device passed all functional and electrical testing.Analysis was performed on the returned generator.The allegation of high impedance was not confirmed.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The allegation of high impedance on the lead was previously reported in mfr report # 1644487-2016-02612.

• Brand Name: PULSE GEN MODEL 106
• 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: 6180909
• MDR Text Key: 62924244
• Report Number: 1644487-2016-02891
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: 106
• Device Lot Number: 4827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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: 28 YR