MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure to Anastomose (1028)

Event Date 09/15/2014

Event Type  Injury  

Event Description

It was initially reported that the patient had their vns explanted.After the explant, the patient picked at the incision and opened the pocket.There was nothing implanted in the patient at that time of the incision being picked open.

Event Description

Additional information was received that product analysis was completed on the lead.A coil break was identified in both the positive and negative lead coils.Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends.Secondary fractures were observed in at least two strands of the quadfilar coils.The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter.Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿.The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.The report issue found with the lead was reported on medwatch 1644487-2014-02836.

Event Description

Additional clinic notes dated (b)(6) 2014 were received stating that the patient experienced wound dehiscence following the explant surgery on (b)(6) 2014.Patient's stitches were taken out and replaced with steri-strips.The patient's chest incision was reported to be open with yellow drainage from it.Patient was provided with antibiotics and was noted to be seeing the surgeon in a few days.

Manufacturer Narrative

Evaluation not related to event.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4147147
• MDR Text Key: 4787521
• Report Number: 1644487-2014-02562
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 102
• Device Lot Number: 202575
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 10/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/27/2014; 04/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2013
• 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): Other
• Patient Age: 26 YR