MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Battery Problem (2885); Communication or Transmission Problem (2896); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

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

Event Date 02/08/2016

Event Type  malfunction  

Event Description

It was reported through clinic notes that a replacement surgery was planned as the patient was at eos = yes (end of service) and due to the report of generator migration.It was explained that the patient noted the generator was dislodged and able to move relatively freely.A battery life calculation was performed which confirmed the device was at eos.It was reported the patient had surgery on (b)(6) 2016 and the surgeon noted the lead was found in a ball when the incision was opened.It looked as if the patient was twisting her generator in the pocked over time.A new generator was placed on the lead and high impedance was found.This high impedance was not previously found since the explanted generator was at eos and could no longer communicate.Due to the high impedance observed, the lead was also replaced.Attempts for additional information have been unsuccessful to date.

Event Description

It was reported the lead was cut into many pieces and intertwined with tissue and would not be returned to the manufacturer for analysis as it was discarded after surgery.The generator was noted it would be returned; however, it has not been received to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The explanted generator was returned for analysis.Pa (product analysis) for the returned generator was approved and the end of service condition was confirmed in the (b)(4) lab as the battery voltage measurement determined the battery was depleted.The end of service condition was the result of normal, expected battery depletion based on the battery life calculation and the electrical test results.The reported failure to program was determined to be caused by the normal battery depletion.The report of the generator migration was beyond the scope of the (b)(4) activities.The device performed according to functional specifications and no abnormal performance or any other type of adverse condition was found.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 5872701
• MDR Text Key: 52337341
• Report Number: 1644487-2016-01816
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2004
• Device Model Number: 302-20
• Device Lot Number: 5986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2002
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR