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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 Problems Fracture (1260); Connection Problem (2900)
Patient Problem Chest Pain (1776)
Event Date 10/15/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Manufacturing report # 1644487-2016-02688 houses the reports of lead fracture, painful stimulation and device disablement that was also reported.Information was received that the patient had chest pain which the patient¿s physician attributed to the presence of the device.The patient then elected to consult a surgeon regarding the pain.The surgeon chose to perform exploratory surgery to determine the cause of the patient¿s pain.The surgeon determined that the patient¿s subcutaneous pocket was lying over a muscle and elected to move the pocket more medially to reduce the patient's pain.The surgeon also tested the insertion of the pin in the header of the generator and found that there was an adequate connection present.No other 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 Key6120637
MDR Text Key60657801
Report Number1644487-2016-02598
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,consum
Reporter Occupation Patient
Type of Report Initial
Report Date 10/31/2016
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 Lay User/Patient
Device Expiration Date12/08/2017
Device Model Number106
Device Lot Number203837
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 10/31/2016
Initial Date FDA Received11/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2016
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) Other; Required Intervention;
Patient Age46 YR
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