• 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 102; 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 102; GENERATOR Back to Search Results
Model Number 102
Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)
Patient Problem Discomfort (2330)
Event Date 01/01/2016
Event Type  Injury  
Event Description
It was reported that the patient has been having some issues with her vns generator.The generator is now reported to be moving in the chest wall and is protruding and rotating causing her significant discomfort.There was no known trauma that may have caused the device to rotate/protrude.The physician reported that this migration began >6 months ago.The patient is planned for full device explant but the explant has not occurred to date.
 
Event Description
Operative notes from (b)(6) 2007 were received on 08/02/2016.Notes state that the generator was inserted into the subcutaneous pocket on the left upper anterior chest and was sutured to the pectoralis fascia with a 3-0 silk suture (non-absorbable suture).No surgical intervention has occurred to date.
 
Event Description
Operative notes were received on 09/13/2016 for the patient's surgery on (b)(6) 2016.The patient had a full device explant on (b)(6) 2016.The reason stated was painful hardware with vns.Notes state the device was not effective for her and it became painful for her.The explanted device was discarded and will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PULSE GEN MODEL 102
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 Key5826374
MDR Text Key50564262
Report Number1644487-2016-01696
Device Sequence Number1
Product Code MUZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 07/05/2016
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 Date08/31/2008
Device Model Number102
Device Lot Number016174
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 07/05/2016
Initial Date FDA Received07/27/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received08/24/2016
10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
-
-