MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT, OPEN TIP, 84 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	44406
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product testing is in progress.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the lumbar peritoneal (lp) shunt system was implanted in (b)(6) 2016.According to the report, the physician suspected that the lumbar vertebra catheter was occluded.Reportedly, since the physician considered the event was a product malfunction issue, a revision was performed to replace the product with another manufacturer's device.At the time of the report, the patient's status was alive-no injury.
Additional Manufacturer Narrative
Approximately 28 cm of the lumbar catheter was returned.The returned catheter was patent and met the requirements for leak testing.Therefore the conditions of this complaint could not be verified by laboratory personnel.Proteinaceous debris was noted in the interior and exterior of the catheter.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ a review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LUMBAR CATHETER KIT, OPEN TIP, 84 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6828182
• Report Number: 2021898-2017-00463
• Device Sequence Number: 16273173
• Product Code: JXG
• UDI-Device Identifier: 00613994653352
• UDI-Public: 00613994653352
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 44406
• Device Lot Number: E00350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention