• 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 103 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 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Insufficient Information
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported the patient was experiencing painful stimulation. The patient was referred for exploratory surgery and possible device replacement. It was reported the patient's device had no high impedance but the physicians opted to completed a prophylactic replacement anyway. Once the new generator was replaced, the impedance was once again within normal parameters. Attempts for additional relevant information have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
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 Key5138542
Report Number1644487-2015-06062
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Followup
Report Date 09/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/03/2015
Device MODEL Number103
Device LOT Number3765
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/08/2015 Patient Sequence Number: 1
-
-