MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Discharge (2225)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported that the patient's generator could be easily moved.At the time of the initial evaluation, the surgeon decided it was not medically necessary to proceed with surgery to address issues with the device migration.A non-absorbable suture was used to secure the generator at the time of the last generator replacement surgery.A subsequent report from the patient on (b)(6) 2016 indicated that she was actually proceeding with surgery.Further information indicated that there issues with seepage from the chest wound and device migration and protrusion.Follow up after her report indicated that her vns system was fully removed on suspicion of infection following a visit to the er and hospital admittance, and she was subsequently released from the hospital.Information received from the explanting surgeon's office confirmed that the patient's system was fully removed.The patient was admitted in-patient on (b)(6) 2016.The generator was reportedly extruding through a dehiscence wound.The generator was removed on a suspected infection in the chest.The lead was also removed to allow for full recovery, although there was no suspicion of infection in the neck.An antibiotic was prescribed.The pathology report for cultures showed negative or negligible for all tests, and showed no growth in culture media.The suture had to be cut for generator removal, indicating it was still intact before explant.No further information was given on potential causes or contributing factors to the device migration, protrusion, or extrusion.The explanting facility does not return explanted products per their internal policy, so return of the removed devices is not expected.The generator device history record was reviewed and found all specifications were met prior to distribution, and the generator was sterilized prior to distribution.

Event Description

Clinic notes were received with information on the patient's medical history.Some conditions were identified that may limit blood supply to certain regions of the body and contribute to wound healing difficulties.The surgeon did assess that he patient did not have risk factors for skin deterioration.However, his awareness of the patient's past medical history was uncertain.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 5688800
• MDR Text Key: 46216231
• Report Number: 1644487-2016-01168
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

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: 01/09/2017
• Device Model Number: 105
• Device Lot Number: 203263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR