• 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

  • 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 Back to Search Results
Model Number 102
Event Date 02/25/2012
Event Type  Malfunction  
Event Description

It was reported that during a clinic appointment, the patient and nurse were swiping the patient's vns magnet. However upon interrogation of the generator, no magnet swipes were registered. Follow up with the physician revealed that he has "no dates of this activation" and did not have additional information. A request to the physician's office was made requesting the patient's programming/diagnostic/magnet history. However, the history has not been received to date. The patient was seen at the clinic again on (b)(6) 2012 and the magnet mode reportedly did not pick up the vns stimulation again after trying two additional times. The site feels that the patient needs a new magnet. However, there is evidence that the patient was receiving stimulation with the magnet because the patient felt dizzy when she swiped the magnet, but when the nurse swiped the magnet, the patient did not feel dizzy. The physician's office thought the dizziness was likely related to a sinus infection. A review of the magnet history in the in-house database showed regularly occurring magnet activations. The last available history was on (b)(6) 2010, with 4706 magnet activations.

 
Event Description

The patient had prophylactic generator replacement surgery on (b)(6) 2012. Attempts for product return have been unsuccessful to date.

 
Event Description

The explanted generator was received by the manufacturer on 07/05/2012. However, product analysis has not been completed to date. The return product form did not provide the reason for replacement.

 
Event Description

Product analysis for the explanted generator was completed. In the lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet functions performed during the output-monitoring test (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet operations for the pulse generator at the programmed settings. 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. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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 Key2511411
Report Number1644487-2012-00850
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/07/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2006
Device MODEL Number102
Device LOT Number011454
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/30/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/16/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-