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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
Event Date 12/21/2015
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2015 were received which indicated that on the morning of (b)(6) 2015 the patient's mother had concerns regarding the incision overlying the clavicle. When she was seen in clinic, it was noted that the midportion of this incision had dehisced slightly. Mom states that there has been some drainage. A decision was made to admit the patient for iv antibiotics with concerns that this was only a superficial infection and could, if not treated aggressively, track down and infected the hardware. She therefore was admitted and has been on iv clindamycin in the hospital since that time. The patient did quite well with her antibiotics and her wound improved significantly. There was no drainage since admission. The erythema, that had been surrounding nearly the entire incision, is essentially resolved. It was therefore felt that the patient was stable for discharge to home with oral antibiotics to complete at least a 2-week course. The parents were given instructions to wash this incision daily with soap and water at this point and to keep it dry and open to air as much as possible the remainder of the time. The patient was at a dosing appointment on (b)(6) 2015 and wound looked very good. Grandmother was at appointment and she stated the wound looks 100% better.

 
Manufacturer Narrative

(b)(4). Additional manufacturer narrative and/or corrected data; corrected data: inadvertently did not include the udi on the initial report.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key5416989
Report Number1644487-2016-00253
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/22/2016
Device MODEL Number103
Device LOT Number4042
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/08/2016 Patient Sequence Number: 1
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