MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42955

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Effects, Unexpected (2099); Vomiting (2144); Lethargy (2560)

Event Date 09/08/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient had a history of a pineal mass tumor as well as associated hydrocephalus.The patient was implanted with a shunt set at 1.5 on (b)(6) 2016.On (b)(6) 2018, the patient was seen due to over the past several months, they had a few episodes that they attributed to significant constipation where they would progress to drowsiness over the course of 24-48 hours but then subsequently improve thereafter.The patient had a similar episode the morning of (b)(6) 2018; however, in the setting of no significant improvement even with aggressive bowel medications over the course of 48 hours and decreased oral intake along with episodes of emesis, the patient's opted to bring them to the emergency room for evaluation.Upon arrival, the patient was found to be lethargic.Noncontrast head ct was performed that demonstrated evidence of slight ventriculomegaly versus previous imaging.Furthermore, a shunt series was found to be within normal limits.Given the patient's neurologic examination in conjunction with concerning radiographic findings plus previously noted concern for recall, the doctor would proceed with a shunt revision.The valve was explanted and replaced with a different valve.During the revision, it was found that the valve was malfunctioning.After the patient's revision, they were acting more like themselves and was almost immediately back to baseline.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 Description

Additional information received reported that in (b)(6) 2016, the patient presented to the emergency room with weakness and altered mental status.They underwent a ct scan and was found to have a pineal region mass as well as associated hydrocephalus.The patient was ultimately diagnosed with pineal blastoma, a brain tumor.After their mass was biopsied, their physicians determined that their tumor had spinal metastases.From the time the patient was implanted with the shunt to (b)(6) 2016, the patient was hospitalized since they began chemotherapy for their brain tumor.Over the following months, the patient continued with their chemotherapy treatments.Her treatment for their blastoma included radiation and chemotherapy.Shortly after, the patient's shunt was recalled, and on (b)(6) 2017, the neurosurgery physicians discussed the recall with the patient's family.However, as the cancer treatment was the primary concerns at the time, the doctors educated the family on signs and symptoms for shunt failure and opted to monitor the patient's progress.The patient completed their chemotherapy and radiation in (b)(6) 2017.Following their release from treatment, they continued regular follow-ups with their physicians for a child status post-cancer.However, in (b)(6) 2018, the patient began to experience problems with their shunt.The patient was taken to the operating room to revise the shunt, and during the operating the doctor noted, "we had intended to remove it regardless, as she had a recalled strata mri valve." the patient was discharged the following day.

• Brand Name: STRATAMR VALVE, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8927978
• MDR Text Key: 155474152
• Report Number: 2021898-2019-00321
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169692718
• UDI-Public: 00643169692718
• Combination Product (y/n): N
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 42955
• Device Catalogue Number: 42955
• Device Lot Number: E12753
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 MO