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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

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CYBERONICS PULSE GEN MODEL UNK; GENERATOR Back to Search Results
Device Problem Fracture (1260)
Patient Problems Laceration(s) (1946); Paralysis (1997); Seizures (2063)
Event Type  Injury  
Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on (b)(6) 2015 which included adverse events involving 7 vns patients.One patient presented vocal cord paralysis and underwent lead replacement.Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant.Two patients presented increased seizures and underwent vns replacement.Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead.The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis.The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia.The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia.The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement.The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement.The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein.The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.
 
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Brand Name
PULSE GEN MODEL UNK
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key5116364
MDR Text Key27203598
Report Number1644487-2015-05985
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Report Date 09/06/2015
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
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