MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	44421
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The peritoneal catheter was returned.The catheter was patent and met the requirements for leak testing.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.Approximately 84 cm of the lumbar catheter was returned.The returned catheter was patent.However, it did not meet the requirements for leak testing due to a tear observed at the 18 cm from the distal end.The catheter met the requirements for the tensile strength and elongation tests.The instructions for use that accompany the device cautions that low tear strength is a characteristic of most unreinforced silicone elastomer materials, and that care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears.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 catheter was not inserted normally in the insertion needle in the vertebrae lumbales.According to the report, resistance was encountered.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6867393
• Report Number: 2021898-2017-00480
• Device Sequence Number: 18996805
• Product Code: JXG
• UDI-Device Identifier: 00643169010789
• UDI-Public: 00643169010789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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: 11/30/2021
• Device Model Number: 44421
• Device Catalogue Number: 44421
• Device Lot Number: E24076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1