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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR
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CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Device Problem Positioning Problem (3009)
Patient Problem Pain (1994)
Event Date 01/20/2015
Event Type  Injury  
Event Description
It was reported that the patient was scheduled for a repositioning of the generator as the current position is painful.Good faith attempts for further information from the physician were unsuccessful.
 
Manufacturer Narrative
 
Event Description
On (b)(6) 2015 the physician reported that the pain was first observed in (b)(6) 2014.No trauma or manipulation that preceded the onset of the pain.The intervention taken was that the generator was repositioned to the axilla.
 
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Brand Name
PULSE GEN MODEL 103
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key4513177
MDR Text Key5490776
Report Number1644487-2015-03813
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 Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2015
Device Model Number103
Device Lot Number3747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received02/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2013
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;
Patient Age30 YR
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