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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 07/05/2017

Event Type  malfunction  

Event Description

It was reported that high impedance was found on the patient's device during generator replacement surgery due to low battery.System diagnostics were not performed on the old generator, and the high impedance was seen after the existing lead was inserted into the new generator.Therefore, it could not be determined if the high impedance was present prior to the surgery.The lead was not revised at that time.Programming history from the old generator was reviewed, and did not show any evidence of high impedance prior to the generator replacement surgery.The explanted generator was discarded by the hospital.Therefore, no analysis could be performed.No further information has been received, and no lead revision has occurred to date.

Event Description

Further information was received that the patient's lead was replaced, which resolved the high impedance.The surgeon later reported that the replaced lead looked twisted or kinked.The surgeon had re-inserted the lead pin into the new generator to rule out lead pin insertion as a possible reason for high impedance.The patient had not experienced any trauma to the vns site prior to the high impedance being identified.No other relevant information has been received to date.

• 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: 6752754
• MDR Text Key: 81368311
• Report Number: 1644487-2017-04228
• 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
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: 302-20
• Device Lot Number: 200431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2007
• 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: 48 YR