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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

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CYBERONICS, INC. PROGRAMMING WAND Back to Search Results
Model Number 201
Event Date 08/19/2008
Event Type  Malfunction  
Event Description

It was reported that the nurse practitioner obtained error messages on her handheld device. She returned both the handheld and programming wand to the manufacturer for analysis. After evaluating the handheld, no anomalies that support the reported complaint were observed so it was determined that the handheld device did not cause of contribute to the reported event. The programming wand was also evaluated and the issues reported by the nurse practitioner where confirmed. The cable was visually examined and no anomalies were identified. Additional analysis showed that the error originated in the serial data cable that had an intermittent conductor. The cable was replaced with a known good serial data cable and all the communication errors cleared. The wand with the new serial data cable passed all functional tests and was operating within the limits of the final electrical test requirements.

 
Manufacturer Narrative

Conclusions: device failure occurred, but did not cause or contribute to a death or serious injury.

 
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Brand NamePROGRAMMING WAND
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nadia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1172122
Report Number1644487-2008-02242
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/19/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2008
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 Manufacturer08/21/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/19/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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