• 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 01/01/2015
Event Type  Injury  
Event Description

It was reported on (b)(4) 2015 that a patient¿s device was explanted on (b)(6) 2015 due to infection and erosion. There was nothing suspected to be wrong with the device, just that it had eroded through the skin. The lead and generator were received for analysis on 02/02/2015. Product analysis for the lead 302-20 was completed and approved on 02/19/2015. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the one and a half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Product analysis for the generator is underway but has not been completed to date. Attempts for additional information have been made and have been unsuccessful to date.

 
Event Description

Product analysis for the patient¿s m105 device was completed and approved on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 013 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts have been made for further information but have been unsuccessful to date.

 
Event Description

It was clarified from the physician that the skin erosion was not a lead issue but skin eroded over the generator with breakdown along the incision line. There was no gross sign of infection although clear contamination was present. The culture taken was positive for propionibacter although it was unable to tell if this was infection or contamination from adjacent skin. Therefore, primary infection was not suspected but contamination/infection after skin erosion may be more likely situation.

 
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 770
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 Key4542162
Report Number1644487-2015-03963
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number105
Device LOT Number203087
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/02/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/26/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2014
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: 02/24/2015 Patient Sequence Number: 1
-
-