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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 11/30/2011
Event Type  Injury  
Event Description

It was reported that ifi=yes was observed, and the generator was implanted on (b)(6) 2011. However, the pt's settings were at a high duty cycle (51%) since the date of implant. Per the mfr battery life estimations for m 103 generators, ifi=yes was expected. The physician lowered the settings to on time=30 sec and off time=1. 1 min to increase the battery life a bit until replacement surgery. The clinic notes from (b)(6) 2011 were received and revealed that the pt was having frequent seizures for the previous three weeks with five to eight seizures per day. The seizures were generalized twitching with cyanosis lasting one to two minutes. In addition, the pt had a fever for the previous couple of days and was seen by his primary care physician who did not find any source of infection. The pt's medications were altered. Attempts for add'l info have been unsuccessful to date. The pt's generator was received, but product analysis has not been completed to date. Return product form indicated reason for explant as end of service/battery depletion.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2425922
Report Number1644487-2012-00095
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 12/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2012
Device MODEL Number103
Device LOT Number201565
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/12/2012
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/22/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2010
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: 01/12/2012 Patient Sequence Number: 1
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