MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS TF; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10093902

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 06/16/2022

Event Type  Injury  

Event Description

Siemens healthineers learned indirectly about this event from a lawyer.The information alleged that a patient had a myelogram procedure of the lumbar spine, which required a lumbar puncture, and during the procedure allegedly a needle was displaced and bent into the patient¿s spine.The patient allegedly was diagnosed with permanent injuries.Although siemens healthineers has to date not heard from the patient, facility, or provider directly regarding any involvement of siemens healthineers, or any of its devices, in the alleged injury, there is a possibility that the event could have involved siemens healthineers axiom luminos tf system as the alleged facility/provider is a customer of siemens healthineers.Siemens healthineers has no further information other than this and is further investigating the event.

Manufacturer Narrative

H3, h6: manufacturers preliminary analysis: it has not been confirmed that a siemens device was involved in the reported event.A root cause has not been determined.Additional information was requested for the ongoing investigation.A supplemental report will be submitted if additional information is received upon completion the investigation.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17835697
• MDR Text Key: 324499853
• Report Number: 3004977335-2023-00124
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 10093902
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female