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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Seizures (2063)
Event Date 04/17/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient developed an infection after a recent generator replacement surgery.The location of the infection was unknown.The patient was hospitalized in the er due to the infection.The patient then experienced status epilepticus due to the infection, so the physician programmed the patient's vns on in response.The nurse did not provide further information about the patient's infection.She reported that the patient had been admitted to the er twice after experiencing status epilepticus, according to her notes.The patient's vns was turned on during the first hospital admission.The patient notably had a fever during the second admission, indicating a possible infection.The patient's status epilepticus resolved after the vns was programmed on in the hospital.Device history records for the generator revealed that the device met all specifications for sterility prior to distribution.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key6695427
MDR Text Key79347028
Report Number1644487-2017-04116
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/08/2018
Device Model Number106
Device Lot Number5137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/13/2017
Initial Date FDA Received07/07/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age30 YR
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