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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
Device Problem High impedance
Event Date 06/24/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

A provider reported that a patient's device was exhibiting high lead impedance. X-rays were provided to the manufacturer for evaluation. X-ray evaluation indicated that the generator placement appeared normal in the left upper chest area and the feedthru wires appeared to be intact. It appeared that the connector pin was not fully inserted into the connector block of the pulse generator. Although the lead wires appeared to be intact at the connector pin, this could not be fully assessed due to the image quality of the x-ray image. A portion of the lead was behind the generator and was therefore unable to be evaluated. There were no obvious lead breaks identified in the visible lead portion, however the presence of a micro-fracture could not be ruled out. No known surgical interventions have occurred to date.

 
Event Description

Surgery was performed on (b)(6) 2015 in order to reconnect the lead to the pulse generator. High impedance was observed in pre-surgical testing. During surgery a test resistor was used to confirm the pulse generator could accurate measure lead impedance after the lead was removed from the generator header. The lead was re-inserted into the header and multiple system diagnostics test were performed, all resulting in normal impedance values. Prior to lead disconnection the physician did not observe any visual connection anomalies. Photos of the lead connection were provided to the manufacturer however due to the angle of the pictures it is not possible to determine if the lead is connected properly in the device header. No patient adverse events were encountered during the pin re-insertion surgery and the patient had a normal heart rate.

 
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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 Key5027471
Report Number1644487-2015-05567
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 07/29/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/12/2016
Device MODEL Number105
Device LOT Number203209
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2015
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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