• 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. LEAD MODEL 302

  • 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. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 11/01/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, a physician reported that he was unable to interrogate a patient¿s device over the last few weeks. The patient stated that he could not feeling stimulation and his voice was not changing, so he doesn't know if his device was working. The physician did not believe the device was at end of service. The patient was seen again on (b)(6) 2013, at which time system diagnostics showed high impedance. The patient¿s device was disabled on (b)(6) 2013 as the patient was experiencing pain in the lower head. The patient was also the programming system was verified to be functioning properly and did verify the high impedance. On (b)(6) 2013, the patient underwent surgery. The generator was replaced, and a system diagnostic showed normal impedance (2000 ohms). Diagnostics after the patient was closed were also within normal limits. System diagnostics later in the day showed high impedance. Surgery is likely but has not taken place.

 
Manufacturer Narrative

Device failure is suspected but did not cause or contribute to a death or serious injury.

 
Event Description

The settings of the new generator were lowered, and the patient may be referred for lead revision at a later date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3534338
Report Number1644487-2013-03896
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2004
Device MODEL Number302-20
Device LOT Number7541
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/23/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/20/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-