MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-30

Device Problems High impedance (1291); Difficult to Remove (1528)

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

Event Date 04/20/2017

Event Type  malfunction  

Event Description

It was reported that in the patient¿s intended generator replacement surgery, the surgeon loosened the set screw on the old generator but was unable to remove the lead pin from the header.He then loosened the set screw until it fell out and was still unable to remove the lead.He attempted to insert small scissors into the header through the opening where the set screw was to try to push the lead out with no success.The surgeon was eventually able to remove the pin out of the old generator.With the lead pin placed in the new generator, device diagnostics showed high impedance several times.The pin on the lead reportedly appeared "bent." the new generator was implanted, but was not connected to the lead pin.Pre-operative impedance was reported to be within normal limits.The device history records of the explanted generator, the implanted generator, and the lead were reviewed by the manufacturer.All quality tests passed prior to distribution.The explanted generator was reported to have been discarded by the explanting facility.Surgery to remove the affected lead has not occurred to date.No additional pertinent information has been received to date.

Event Description

Operative notes from the date of the generator replacement surgery were received and reviewed by the manufacturer.The notes showed that the physician had loosened and eventually removed the generator setscrew, but the pin was stuck in the old pulse generator and would not come out.The physician used wire cutters to cut part of the lead¿s silastic assembly, which exposed the distal end of the lead.The surgeon pushed it out of lead header, and the lead pin was found to be bent.He attached the new generator and found impedance was high.He loosely connected to pulse generator, placed the new vns generator and lead back in the cavity, and closed the wound.Further information showed the surgeon had assessed the pin was over-tightened in the previous surgery and was bent before it would come out.No additional pertinent information has been received to date.

Event Description

It was reported that the new generator was not programmed on following the replacement surgery due to the high impedance issues.

• Brand Name: LEAD MODEL 303
• 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: 6568397
• MDR Text Key: 75210581
• Report Number: 1644487-2017-03813
• 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: 08/22/2017

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: 07/31/2013
• Device Model Number: 303-30
• Device Lot Number: 200287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided; 07/31/2017
• Supplement Dates FDA Received: 06/12/2017; 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2006
• 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: 44 YR