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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNK Back to Search Results
Event Date 02/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the company representative that he was informed by the physician that the patient showed high lead impedance at the office visit after a battery replacement surgery. Patient is also having an increase in seizures now. Seizures were well controlled prior to battery replacement. Patient was taken into surgery ((b) (6)2010) for the high lead impedance. His connector pin was re-inserted and diagnostics showed within normal limits in the operating room. Patient then had his appointment with the neurologist and showed high lead impedance again. However, when the patient turns his head to the right then, the diagnostics are within normal limits. It was suspected that the lead issue was positional. Patient will likely have another revision surgery. Good faith attempts to obtain additional information have been unsuccessful till date.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1689709
Report Number1644487-2010-01100
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/06/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/06/2010 Patient Sequence Number: 1
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