MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	92866
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
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 valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that a surgeon was under the impression that a shunt patient of theirs may be experiencing reverse polarity.The patient was implanted in (b)(6) 2017, and a march ct scan showed over drainage at a setting of 2.0.The settings were then adjusted to 2.5 to decrease drainage.According to the report, the surgeon sent pictures of an x-ray of the valve to a design engineer at medtronic, but the picture was inverted.The surgeon then pulled up the x-ray exam on a monitor in the operating room (or) and a picture was sent to the design engineer again.With this correctly orientated picture, they were able to determine that the shunt was set between 0.5 and 2.5 causing it to operate at the 2.5 level.This was the level the surgeon was hoping for.Reportedly, even with that information, the surgeon seemed to believe the valve was suffering from reverse polarity since in (b)(6), a follow-up magnetic resonance imaging (mri) demonstrated extreme ventricular decompression with bilateral subdural fluid collecti ons from overdrainage and removed the shunt from the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6616875
• Report Number: 2021898-2017-00303
• Device Sequence Number: 867163
• Product Code: JXG
• UDI-Device Identifier: 00643169010413
• UDI-Public: 00643169010413
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• 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): 05/10/2017

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: 07/31/2019
• Device Catalogue Number: 92866
• Device Lot Number: E16262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 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: Required Intervention
• Patient Age: 29 MO
• Patient Weight: 17