LEAD MODEL 302 302-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-05 for LEAD MODEL 302 302-20 manufactured by Cyberonics - Houston.

Event Text Entries

[186786365] Patient presented with high lead impedance and low output current. It was also noted that the patient had a lack of efficacy with the device that started at the same time as the high lead impedance. The physician's office does not know the reason for the high lead impedance, or if there was a gradual increase in impedance. The patient later reported that she was attacked by a dog prior to the high impedance reading. The patients device was later interrogated and system diagnostics showed high lead impedance and low output current. The patients output current was reduced and system diagnostics were again run. The output current was ok; however, high lead impedance was again seen. Ap and lateral chest and neck x-ray images were received. The generator was located in the upper left chest. Due to the angle and quality of the image, it cannot be assessed if the connector pin is fully past the second connector block or if the filter feedthru wires were intact. The lead was visualized in the chest and neck. The lead appears to be routed behind the generator. The lead wires appear to be intact at the connector pin. No sharp angles were observed in the lead. The lead was assessed for fractures and no gross fractures or discontinuities were noted. Based on the x-rays received, the cause for the high impedance cannot be determined at this time. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. No known relevant surgical intervention has occurred to date. No additional or relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644487-2020-00384
MDR Report Key9793811
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2020-02-10
Date Mfgr Received2020-02-10
Device Manufacturer Date2006-12-06
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. RACHEL KOHN
Manufacturer Street100 CYBERONICS BLVD SUITE 600
Manufacturer CityHOUSTON TX 77058
Manufacturer CountryUS
Manufacturer Postal77058
Manufacturer Phone2812287200
Manufacturer G1CYBERONICS - HOUSTON
Manufacturer Street100 CYBERONICS BLVD SUITE 600
Manufacturer CityHOUSTON TX 77058
Manufacturer CountryUS
Manufacturer Postal Code77058
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD MODEL 302
Generic NameLEAD
Product CodeMUZ
Date Received2020-03-05
Model Number302-20
Lot Number1766
Device Expiration Date2009-11-28
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCYBERONICS - HOUSTON
Manufacturer Address100 CYBERONICS BLVD HOUSTON TX 77058 US 77058


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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