MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Impaired Healing (2378)

Event Date 09/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient presented to the er with wound healing issues following recent generator replacement surgery.The patient was evaluated by the surgeon and it was noted that the corner of the generator was exposed.The wound dressings were changed and the patient was prophylactically prescribed antibiotics.The patient was referred for would flap surgery.At a follow-up appointment on (b)(6) 2016, it was noted that the would was healing and was about the size of a dime.Additionally, the generator was no longer exposed.The patient was once gain prophylactically prescribed antibiotics and given additional wound supplies to continue dressing the wound.A few weeks later, the patient's care home reported that the patient had been "horsing around with a friend" which caused the wound to open again and the generator was exposed.When the patient was evaluated by the surgeon on (b)(6) 2016, the generator and lead were out of the pocket.It was noted that the lead was broken.The surgeon then explanted the lead and generator in the office and the explanted products were given to the patient's caregivers.The wound flap surgery was then canceled.A review of manufacturing records showed that the generator was sterilized prior to distribution.

• Brand Name: PULSE GEN MODEL 106
• 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: 6117942
• MDR Text Key: 60555347
• Report Number: 1644487-2016-02696
• 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
• Report Date: 10/28/2016

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: 01/15/2018
• Device Model Number: 106
• Device Lot Number: 203698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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: 19 YR