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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/01/2009
Event Type  Injury  
Event Description

It was initially reported that the patient was experiencing painful muscle spasms during stimulation in the upper limb. Recent diagnostics performed indicate that diagnostics were within normal limits. The patient was also said to not have had efficacy with the therapy. The site believes that there is a malfunction of the device, and it is expected that the patient will have her system replaced. It was later noted that high impedance was observed, but no diagnostics performed were provided in relation to normal mode diagnostics performed when initially report on patient painful stimulation and muscle spasms. Good faith attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1513594
Report Number1644487-2009-02322
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL Number302-20
Device LOT Number200269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/17/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
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: 10/16/2009 Patient Sequence Number: 1
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