MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Extrusion (2934)

Patient Problem Skin Erosion (2075)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was being scheduled for emergency surgery.The generator was extruding through the skin.The surgery occurred on (b)(6) 2015 for generator replacement.The extrusion was attributed to the numerous past surgeries the patient experienced at the site of her generator and subsequent scar degradation.The surgeon chose to implant the generator on the right side to avoid aggravating the site of the injury.The explanted generator was discarded after the surgery, so product return and analysis is not possible.

Event Description

Clinic notes were received indicating that a patient reported that her generator incision started opening up on approx.(b)(6) 2016 and began to drain.The wound was red and warm but the patient had no fever.A provider evaluated the patient on (b)(6) 2016 and noted she has had some breakdown of the left anterior chest due to several prior vns surgeries.The provider's commentary states that the patient feels the condition is a bit better and the provider notes that there was still some drainage but it had lessened from the time of an evaluation a few days prior.The area was non tender to the touch and there was no sign of fever.The provider concluded that the area was not looking worse and elected to continue oral antibiotics and local wound care.A subsequent visit on (b)(6) 2016 with another provider indicated that no further drainage had occurred.The visit notes indicated that there was a similar amount of induration beneath the skin but no signs of infection.A visit on (b)(6) 2016 with this same provider indicated the patient was still having no further drainage and no change in the induration beneath her skin under her previous incision, nearly identical to her last visit.No further invention was deemed necessary and the provider indicated he only needed to see the patient as necessary.On (b)(6) 2016 the provider reported that the patient had experienced an infection due to her left-sided lead and the patient was referred for removal surgery.No known surgical interventions have occurred to date.

Event Description

Review of manufacturing records confirmed sterilization prior to distribution for the lead and all of the generators implanted at the time of the original extrusion event and thereafter.On (b)(6) 2016 the patient underwent removal of her lead and right-sided generator and treatment of her prior left-sided drainage wound.Dense scar tissue was encountered which precluded removal of the lead electrodes.No obvious infection was noted at the site of the right-sided generator.The left chest-wall incision was opened and no obvious infection was encountered and the scarred wall of the previous pocket for the generator was excised in its entirety and sent for culture.The drainage wound which was 3 cm inferior to the left-sided pocket was cultured and excised.No obvious infection was encountered, so the previously planned wound vac was not employed.Attempts to obtain the explanted products for product analysis have been unsuccessful to date.

Event Description

The manufacturer was informed that the devices explanted during the (b)(6) 2016 surgery were discarded by the explanting facility.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 5275266
• MDR Text Key: 32985320
• Report Number: 1644487-2015-06632
• 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,Followup,Followup
• Report Date: 11/12/2015

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: 08/22/2016
• Device Model Number: 103
• Device Lot Number: 4042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2016; 06/20/2016; 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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: 56 YR