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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-07 for * manufactured by *.

Event Text Entries

[348419] A case of possible cjd transmission from a right kidney transplant. The recipient developed neurological disease suggestive of cjd. Upon further questioning of the recipient's family, they had displayed some changes in gait, suspicious falls and possible delusions/hallucinations prior to the transplant. The pt's diagnosis was made by mri and 14-3-3 protein, but no brain biopsy was done. A neuropathologist was consulted who stated that more likely this was a case of spontaneous disease process in the recipient rather than a transmission from the donor. Fda received the records of the kidney donor. A review found no evidence of risk factors for cjd or symptoms of a degenerative neurological condition. Donor died of a intracerebral hemorrhage from a ruptured aneurysm. No other recipients have developed any other symptoms. Other tissues from the same donor that had been transplanted included: corneas, liver, heart, left kidney. Health dept was also involved in this investigation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034572
• MDR Report Key: 571574
• Date Received: 2005-02-07
• Date of Report: 2005-02-07
• Date of Event: 2004-11-23
• Date Added to Maude: 2005-02-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: LMO
• Date Received: 2005-02-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 561426
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2005-02-07