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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 Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)
Event Date 04/22/2015
Event Type  Injury  
Event Description
It was reported that the recently implanted vns patient developed an infection.During the post-operative period, the patient picked at the generator site and the incision opened.The incision site was re-closed, covered, and healed so the sutures were later removed.During the weekend of (b)(6) 2015, the patient went to the er as she had picked at the generator site and reopened the incision.The lead incision site had healed well; however, the generator incision site was partially opened and the patient¿s generator was exposed.Wound cultures were (b)(6).The patient underwent surgery on (b)(6) 2015 to explant the generator and lead.During the procedure, it was noted that dense scar tissue surrounding the patient¿s nerve.The scar tissue was lysed and the electrodes were able to be removed.The patient has not been re-implanted to date.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
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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
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 Key4838570
MDR Text Key5909446
Report Number1644487-2015-04881
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 Medical Assistant
Type of Report Initial
Report Date 05/18/2015
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
Device Expiration Date07/31/2016
Device Model Number103
Device Lot Number3993
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 05/18/2015
Initial Date FDA Received06/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2014
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;
Patient Age22 YR
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