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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 07/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient's generator site incision opened up. A revision surgery was planned, but the surgeon had assessed that the full vns system required removal. An infection was reportedly confirmed at that time, and the lead was extruding and in the infected area prior to removal. The explant procedure occurred on (b)(6) 2016. The explanted generator and lead were received for product analysis on 08/23/2016. Follow up with the surgeon's office showed that the patient's generator site opened in approximately (b)(6) 2016. Prior to the incident, the patient had developed a white bump over his generator site. His caregiver had scratched it off and caused bleeding, and the patient went to the er. Cellulitis and infection was suspected prior to the explant surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

 
Event Description

Product analysis was completed on the returned lead portion on (b)(6) 2016. Note that a portion of the lead body including the electrodes was not returned for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device. Product analysis was completed on the returned generator on (b)(6) 2016. Visual examination showed only explant-related observations; no surface abnormalities were noted on this device. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 074 volts and showed an ifi=no condition. Review of the internal device data showed no anomalies, with any noteworthy impedance changes occurring after the device explant. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 105
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 Key5925113
Report Number1644487-2016-01986
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/05/2016
Device MODEL Number105
Device LOT Number203191
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/23/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/06/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2014
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: 09/02/2016 Patient Sequence Number: 1
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