• 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
Event Date 02/01/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, a vns implanting surgeon the vns patient's generator had migrated and the lead was pulling. On (b)(6) 2012, the neurologist reported that the vns patient was complaining of pain around the generator site close to her underarm and neck for a couple of months. The patient stated that the areas are tender and painful but is not particular to stimulation. She also says that the lead is protruding at the neck site. The physician referred the patient to a surgeon regarding the protrusion. The patient also reported that she doesn't feel stimulation when she swipes her magnet. The patient's seizures however were actually doing better. The neurologist later reported that the patient's generator has actually flipped on its side in the patient's chest so instead of lying flat and flush it is sticking out which is causing the pulling the patient feels on the lead. The patient has been referred to a surgeon for prophylactic replacement due to the migration and to alleviate the potential for infection. The patient denied any manipulation or trauma that could have caused the device to have moved to its side. The patient stated that the generator is able to be interrogated but she still does not feel any magnet stimulation when she swipes the magnet. The reason the patient was not feeling magnet stimulation was not due to becoming accustomed to the magnet settings according to the manufacturer's consultant. Attempts for further information were made but no additional information was received from the physician. Although surgery is likely, it has not yet occurred.

 
Event Description

Additional information was received on (b)(6) 2012, when the operative report was received from the patient's surgery on (b)(6) 2012. Preoperative diagnostics showed that device to be working well with appropriate impedance and a battery swipe appeared to be functioning according to the notes. The notes further state that once they got the patient's chest open, they removed the generator and reattached it and cleaned out the generator pocket to have a better position for it. When they re-tested the generator after this, diagnostics showed the generator was at end of life. The surgeon stated that this may have been exposed to electrocautery. They tested the device several times and it would not function. The generator was therefore replaced and diagnostics showed results within normal levels of 2500 ohms. The patient's settings were reset to the previous settings without difficulty and the device was rechecked with good results. The notes also indicate that prior to surgery the patient was having good benefit from vns but this was starting to be less functional as the generator itself appeared to may have rotated and was causing her some discomfort at the incision site. The patient was also reported to have not believed the battery was working well. The patient later indicated that sometime around (b)(6) 2012, she contacted her neurologist because she was having pain around her generator; under her arm and in her neck. The patient also indicated that her magnet was not working and her lead was protruding from the neck and catching on clothing which caused pain. She was also short of breath. The physician then ordered x-rays to rule out bronchitis or pneumonia since she was short of breath. The x-rays showed nothing so the physician assumed it was a problem with her vns device and referred her to the surgeon.

 
Manufacturer Narrative

 
Event Description

On (b)(6) 2012 the patient reported that she has a "knot" in her neck. The patient also indicated that the lead is still protruding from her neck.

 
Event Description

Additional information was received on (b)(6) 2012, when it was discovered that the vns patient had been scheduled for prophylactic battery replacement surgery that day. The patient was complaining of lead poking the skin by the generator. System diagnostics were performed prior to surgery and the impedance was within normal limit of 3757 ohms. Upon re-positioning of the generator, the surgeon touched the generator with the electrocautery in error. When system diagnostics were then performed after, the device alerted to eos when it had previously not been at eos. The generator was then replaced. A system diagnostics test after replacement showed the device to be functioning properly at 2471 ohms. The explanted generator could not be returned to the manufacturer for product analysis as the hospital does not return devices.

 
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 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2574353
Report Number1644487-2012-01215
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/01/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/30/2013
Device MODEL Number103
Device LOT Number201860
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/05/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/30/2011
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: 05/15/2012 Patient Sequence Number: 1
-
-