MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SNAP SHUNT ASSEMBLY, SMALL, PERFORMANCE LEVEL 1; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	24027-1
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Headache (1880); Therapeutic Response, Decreased (2271); Malaise (2359)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, reflux, pressure-flow, and preimplantation testing.There was pro teinaceous debris observed within the interior and exterior of the valve.The valve did not meet the requirements for leak testing due to a tear noted in the side of the delta chamber.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing showed no anomalies.All valves are 100% tested at the time of manufacture.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 patient complained about headaches, feeling of pressure on the head, and malaise.According to the report, the surgeon presumed that the device maybe obstructed.Reportedly, the device was partially explanted, and the patient experienced no injuries.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, reflux, pressure-flow, and preimplantation testing.There was pro teinaceous debris observed within the interior and exterior of the valve.The valve did not meet the requirements for leak testing due to a tear noted in the side of the delta chamber.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing showed no anomalies.All valves are 100% tested 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: DELTA SNAP SHUNT ASSEMBLY, SMALL, PERFORMANCE LEVEL 1
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6603289
• Report Number: 2021898-2017-00293
• Device Sequence Number: 838468
• Product Code: JXG
• UDI-Device Identifier: 00643169497177
• UDI-Public: 00643169497177
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2017

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: 05/31/2021
• Device Catalogue Number: 24027-1
• Device Lot Number: E12567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: Not provided; 06/01/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 06/29/2017; 10/04/2017
• 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
• Patient Age: 61 YR