ELECTRODES, LT-4500 N/A 106130-12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for ELECTRODES, LT-4500 N/A 106130-12 manufactured by Ebi, Llc..

Event Text Entries

[188859071] Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2020. The customer has indicated that the product will not be returned to zimmer biomet for investigation because the patient is still using the product. The investigation is in process. Once the investigation has been completed, a follow up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00013 and 0002242816-2020-00014. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10


[188859072] It was reported that the patient was experiencing pain from the spinalpak stimulator. The patient was using the spinalpak stimulator with the lt-4500 and 72r electrodes. The patient stated that the pain was on the right side of her back in the kidney area and across the hip. The patient stated that the pain is below the skin and the pain level is a 10, on a scale of 1-10. The patient stopped using the stimulator and the pain did not go away. The patient called their doctor and was prescribed ibuprofen and advised not to use the stimulator for a week. The patient believes that the pain was from the inflammation of the incision. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002242816-2020-00012
MDR Report Key9627090
Report SourceCONSUMER
Date Received2020-01-24
Date of Report2020-01-24
Date Mfgr Received2020-01-08
Date Added to Maude2020-01-24
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 ContactSARA DAILEY
Manufacturer Street399 JEFFERSON ROAD
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal07054
Manufacturer Phone9732999300
Manufacturer G1EBI, LLC.
Manufacturer Street399 JEFFERSON ROAD
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal Code07054
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameELECTRODES, LT-4500
Generic NameELECTRODES
Product CodeLOF
Date Received2020-01-24
Model NumberN/A
Catalog Number106130-12
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEBI, LLC.
Manufacturer Address399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-24

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