MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET EDMS, INTERLINK, EDM LUMBAR DRAINAGE CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	46917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.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 had a slit/tear.According to the report, there was no injury to the patient, and they had been discharged.
Additional Manufacturer Narrative
Only the lumbar catheter was returned.The catheter did not meet the requirements for leak testing.The catheter was observed to be sheared off approximately 32 cm from the distal end.It is unknown how or when the damage occurred.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.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: DUET EDMS, INTERLINK, EDM LUMBAR DRAINAGE CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6775221
• Report Number: 2021898-2017-00429
• Device Sequence Number: 13487499
• Product Code: JXG
• UDI-Device Identifier: 00613994445407
• UDI-Public: 00613994445407
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K983799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 08/31/2019
• Device Catalogue Number: 46917
• Device Lot Number: 211965230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 102