MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR DRAINAGE KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46441
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the healthcare professional (hcp) experienced difficulties during the placement of the lumbar catheter.It was stated there was a possible problem with the tuohy needle due to misalignment between the catheter and needle.There reportedly was a possibility of the catheter breaking, but the hcp was careful during the manipulation and completely explanted the product.There were no patient symptoms or complications associated with the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the misalignment was determined on the second dot, cca 20cm of length.It was stated the catheter was blocked on that distance, and they could not remove if from the body.After the removal of the needle, the catheter was able to be explanted but not along with the needle.The hcp's did not notice any visible defect with the tuohy needle or the catheter.It was noted they did not perform any adjustment of the position of the catheter in any direction.
Additional Manufacturer Narrative
The entire device was returned.Approximately 79 cm of the lumbar catheter returned.The catheter was patent and met the requirements for leak testing.No anomalies were noted.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7592871
• Report Number: 2021898-2018-00286
• Device Sequence Number: 1814149
• Product Code: JXG
• UDI-Device Identifier: 00643169471511
• UDI-Public: 00643169471511
• Combination Product (Y/N): N
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 46441
• Device Catalogue Number: 46441
• Device Lot Number: 211950671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/13/2018; 07/13/2018; 08/08/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/26/2018; 07/27/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 75