• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 08/12/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported by the physician's office that the patient was admitted to the hospital due to infection. The patient was going to be replaced; however, the site did not have a replacement generator and needed a company representative to provide one for the replacement. A company representative later confirmed he attended the replacement surgery on (b)(6) 2016. He confirmed the patient's generator was replaced due to infection and the new generator remained programmed off. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The explanted generator was received by the manufacturer for analysis. Product analysis is expected, but has not been completed to date.

 
Event Description

Product analysis (pa) for the returned generator was completed. While the reported infection is beyond the scope of the activities performed within the pa lab, the potential contributing factors have been considered and evaluated and none were found to exist in the reported situation. The diagnostics for the generator were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

 
Event Description

It was later reported by the physician that the infection was first observed within the clinic on (b)(6) 2016. Due to this information, additional follow up was performed at which point it was explained that the patient had a subsequent infection and that the original infection was first observed on (b)(6) 2016. It was noted the family had called the physician's office on (b)(6) 2016 with a report of swelling, the patient went to the ed (emergency department) on (b)(6) 2016, and the generator device was replaced on (b)(6) 2016. During the replacement surgery on (b)(6) 2016, the chest wall was washed out and the patient was placed on a normal regimen of iv antibiotics. It was noted the believed cause of the infection was due to the placement of the device in the axillary region, as opposed to the chest, and the patient is in a wheelchair. It is felt that the sweat is a contributing factor in the wound getting infected. The information regarding the second infection has been reported in mfr. Report 1644487-2016-02467.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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 Key5942349
Report Number1644487-2016-02046
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 08/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/05/2017
Device MODEL Number105
Device LOT Number4264
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/05/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/12/2016 Patient Sequence Number: 1
-
-