• 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. PROGRAMMING WAND

  • 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. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 08/28/2008
Event Type  Malfunction  
Event Description

Reference mdr number 1644487-2008-02341. Product returned with a handheld and programming software. Product analysis was performed on the returned programming wand. The serial data cable, which produced communication errors, had an intermittent conductor and the returned battery was depleted. A known good bench serial data cable and the battery were substituted. All communications errors cleared. Root cause for a complaint alleging a non-functional programming wand is the depleted battery. This could be attributed to user oversight or possibly not knowing that the battery needs to be replaced on occasion. After the serial data cable and the battery were substituted, passing functional test results verified consistent communication of the wand. After the serial data cable was substituted, the programming wand was electrically tested and was operating within the designed limits of the final electrical test requirements. No visual anomaly was identified. Continuity testing of the battery cable passed.

 
Manufacturer Narrative

Device malfunction occurred but did not cause or contribute to a death or serious injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1198388
Report Number1644487-2008-02476
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/02/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number201
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/05/2008
Is The Reporter A Health Professional? No
Date Manufacturer Received10/02/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-