MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 12/12/2015

Event Type  Injury  

Event Description

A physician reported to an international distributor that a patient developed an infection of the wound (generator incision) around the patient's left chest.The physician was unable to diagnose the cause of the infection by physical examination but indicated the event was not related to vns.Cultures were not taken but the physician believed an infection was present due to the presence of an abscess at the site.There was no indication of patient manipulation or trauma.The last known device check indicated normal vns operation with normal battery and lead impedance status.The patient was admitted to the hospital for treatment and antibiotic medication was administered but was reported to be ineffective.The physician elected to explant the pulse generator and lead and the patient was later discharged.The explanted devices were discarded by the explanting facility.Review of manufacturing records confirmed sterilization of both the pulse generator and lead prior to distribution.The patient may be re-implanted at a future date but no known re-implantation has occurred to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 5405115
• MDR Text Key: 241274013
• Report Number: 1644487-2016-00174
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/07/2016

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: 02/29/2016
• Device Model Number: 105
• Device Lot Number: 202851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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: 11 YR