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

Model Number 42955

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Incontinence (1928); Muscle Weakness (1967); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); Cognitive Changes (2551); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had retained counsel who alleged a revision of the shunt was required.

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 september 2016, the patient was diagnosed with normal pressure hydrocephalus.The patient was seen by a doctor who recommended they undergo a ventriculoperitoneal (vp) shunt placement, and on (b)(6) 2016, the patient was implanted with a vp shunt which was located behind their right ear.The shunt was initially set to a drainage level of 1.5.On (b)(6) 2017, the patient saw the doctor for a routine postoperative visit.They communicated that they felt their cognition and balance were improving; however, at the (b)(6) 2017 follow up appointment, they noticed that they were "still having issues with their left side being weaker than their left" as well as "some issues with coordination at times." around may of 2017, the patient's daughter noticed that the patient's sense of balance had begun to decline.On (b)(6) 2017, at the patient's follow-up appointment, it was noted that they had problems with maintaining their balance "similar to what they had priorto the shunt." it was also noted that cognitively they remained sharp but did notice lately that they were more fatigued and had more trouble concentrating than they had at their last visit.Their shunt was adjusted from the initial 1.5 setting to 1.0.On (b)(6) 2017, the patient attended another follow up appointment where they reported that they continued to experience problems with their balance as well as increased trouble concentrating.A head ct was performed and showed enlarged ventricles that were about the sameas prior to their shunt.The shunt was subsequently readjusted from 1.0 to 0.5.Around (b)(6) 2018, the patient was admitted to the hospital after experiencing complications from hydrocephalus.On (b)(6) 2018, the patient was seen by a new neurosurgeon who noted that the patient had subjectively deteriorated according to the patient's daughter since their last appointment.The doctor observed that the patient's gait was slight unsteady.On (b)(6) 2018, the patient and their daughter returned to the doctor's office for evaluation.The doctor noted that the patient presented to the office via wheelchair accompanied by their daughter.It was indicated that they continued to experience neurological decline and urinary incontinence.It was also noticed that their gait was slightly worse.On (b)(6) 2018, the patient's shunt was removed and replaced with a different make and model.At the time the patient had the revision procedure, it was stated it was due to recurrence of symptoms associated with hydrocephalus, and further noted that the particular valve was recalled.

• 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: 7866296
• MDR Text Key: 119919810
• Report Number: 2021898-2018-00456
• Device Sequence Number: 1
• Product Code: JXG
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 42955
• Device Catalogue Number: 42955
• Device Lot Number: E18558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• 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