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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
Event Date 08/22/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a physician could not interrogate a vns patient's device on (b)(6) 2016. It was reported that the day before, on (b)(6) 2016, the patient underwent surgery due to infection where the wound was cleaned without explanting the device (event reported in the medwatch report 1644487-2016-02050). Before the surgery, the device was switched off without any issues. The physician did not perform a diagnostics test, but there was no issue with the patient's generator. After the surgery, when the physician tried to switch the device back on (on (b)(6) 2016), communication issues occurred. The physician tried many times before she could finally interrogate the generator. It then stated that the generator was at end of service. The device was implanted in (b)(6) 2016 (2 months ago). Diagnostics test showed: low output current, impedance ok, 2806 ohm, eos yes. It was reported that another physician came to help using her programming system, but she could never communicate with the device. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Further information from the physician indicated that, 10 days after the surgery they still could not interrogate the patient's generator. As the infection was still there, it was decided to explant the device. It was reported that the patient underwent explant surgery on (b)(6) 2016. The return of the explanted device is expected but it has not been received to date.

 
Event Description

Further information from the surgeon was received indicating that during the surgery, an equipment could have touched the device, which could have caused the premature end of service. The explanted generator was returned to the manufacturer on 10/31/2016. Analysis is underway but it has not been completed to date.

 
Event Description

Analysis of the returned generator was completed. It indicated that the reported allegation of ¿asic latch-up condition¿, could be verified in the pa laboratory. Review of the data downloaded from the pulse generator indicated that the pulsedisabled byte was set to a value that represents a vbat

 
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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 Key5948700
Report Number1644487-2016-02051
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 08/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2017
Device MODEL Number103
Device LOT Number300312
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/30/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/11/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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