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

Model Number 105

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

Patient Problem Unspecified Infection (1930)

Event Date 05/30/2014

Event Type  Injury  

Event Description

It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant the patient¿s generator due to infection.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Analysis of the returned generator was completed.There were no adverse functional, mechanical, or visual issues identified with the returned generator.Results of diagnostic testing indicated the device was operating properly.Electrical test showed that the pulse generator was operating within specification.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description

It was reported that the patient had recently undergone generator replacement prior to the infection.It was reported that the patient presented with erythematous swelling to the wound and debridement occurred with explant.The generator was cultured and noted to have staphylococcus aureus.The patient is being treated with oral antibiotics.The explanted generator was received for analysis.The returned product form indicated that the generator was not replaced during explant surgery.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Age at time of event, date of birth; corrected data: the previously submitted mdr inadvertently did not provide age for the patient.Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date.Device available for evaluation?; corrected data: the previously submitted mdr inadvertently did not provide the information.

Event Description

It was reported that vns patient underwent generator replacement on (b)(6) 2015.The lead impedance of the implanted vns system was 1993 ohms.It was reported that the decision made for replacement is due to patient having increase in seizures without the vns therapy.

• 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: 4012597
• MDR Text Key: 4775649
• Report Number: 1644487-2014-02029
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 105
• Device Lot Number: 202801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• 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