• 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 04/22/2014
Event Type  Malfunction  
Event Description

It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.

 
Event Description

It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

 
Event Description

Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.

 
Event Description

Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.

 
Manufacturer Narrative

Only the generator was replaced.

 
Event Description

Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.

 
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 Key3845253
Report Number1644487-2014-01384
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number103
Device LOT Number3590
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/10/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/02/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2013
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: 06/03/2014 Patient Sequence Number: 1
-
-