MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/11/2014

Event Type  Injury  

Event Description

Following patient's generator replacement surgery on (b)(6) 2015, it was noted that the lead was protruding at the generator site.Clinic notes dated (b)(6) 2015 indicate that the surgeon might perform another surgery to get the wire in better position so that it does not stick up.Other than the lead protrusion, the incision is well healed and there is no sign of infection.Additional information was received from the physician that the patient is a fiddler/picker and that she had twisted the lead at the generator site, which caused the lead to protrude a little.On (b)(6) 2015, the physician readjusted the position of the lead so patient can avoid picking at it and no devices were replaced.It was reported that the surgery was for the comfort of the patient and to reposition it so patient does not pick at it.Notes dated (b)(6) 2015 indicate that the patient's surgery on (b)(6) 2015 was to correct the protrusion of the lead as it was bothersome and painful upon palpitation.During surgery, an egress of old blood clot was noted and was evacuated.The surgeon noted that the generator had turned somewhat.The generator and lead were repositioned to minimize the chance for the lead poking up through the skin.The generator was tested within the pocket and noted to have normal functioning and good impedances.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5125283
• MDR Text Key: 27445302
• Report Number: 1644487-2015-06002
• 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
• Report Date: 09/18/2015

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: 07/31/2016
• Device Model Number: 103
• Device Lot Number: 3991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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: 28 YR