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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 06/24/2011
Event Type  Injury  
Event Description

On (b)(6) 2011, clinic notes from a vns treating physician were received through case mgmt. Review of the clinic notes revealed that on (b)(6) 2010, the pt was experiencing pain in their neck and shoulders on and off. The physician decreased the vns pulse width to see if it would help the pt. The physician also reported that on (b)(6) 2011 the pt had seizures at night, but did not try and swipe their magnet. In clinic notes dated (b)(6) 2011, the physician reports that the pt has a history of neck pain. The physician also reported that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. Due to the pt's flare of symptoms, the physician referred the pt for prophylactic battery replacement. In clinic notes dated (b)(6) 2011, the physician provides further info about the pt's history of neck pain, stating that it spreads into the occipital area in keeping with neuralgia. The physician again reports that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. The mfr's consultant later reported that the physician believes the pt's pain was not related to vns. Surgery has not yet been scheduled. Attempts for additional info regarding the pt's seizures have been made to the physician, but no further info has been received to date. When further info is received, it will be reported. A blc performed with the programming history in the mfr's programming history database which revealed negative yrs until eri = yes.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2180923
Report Number1644487-2011-01659
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/28/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2004
Device MODEL Number102
Device LOT Number7272
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/28/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2002
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: 07/22/2011 Patient Sequence Number: 1
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