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

Model Number UNKNOWN-S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Hemorrhage, Cerebral (1889); Hemorrhage, Subdural (1894); Seizures (2063); Seroma (2069); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Ronald j.Benveniste, samir sur.Delayed symptom progression after ventriculoperitoneal shunt placement for normal pressure hydrocephalus.Journal of neurological sciences, 393 (2018), doi: 10.1016/j.Jns.2018.08.002.Abstract: normal pressure hydrocephalus (nph) is generally treated with ventriculoperitoneal shunts (vps), with improved symptoms in the majority of patients.We performed a retrospective chart review study in order to describe patterns of, and risk factors for, delayed symptom progression after initially successful vps placement.69 consecutive patients underwent vps placement for nph, and were followed for a minimum of 12 months postoperatively.55 patients (80%) had objective improvement in their nph symptoms after surgery.Of these, 27 patients (49%) developed delayed deterioration of at least one of their nph symptoms, at a mean of 28.3 months postoperatively (range, 3¿77).1 of the 27 patients was found to have shunt malfunction; 19 had specific clinical or imaging evidence of shunt function.6/19 patients had transient improvement in their symptoms (lasting 30 days or more) after adjustment of their programmable shunt valves (32%), although symptoms in all of these patients later worsened.During a mean follow up period of 44.4 months (range, 15¿87), 12 patients (44%) received other neurological diagnoses felt to at least partially explain their symptoms.Increased patient age was associated with likelihood of delayed symptom progression.We conclude that delayed symptom progression is common after vps placement for nph, including after initial symptom improvement; that symptom progression can often be temporarily palliated by shunt valve pressure adjustment; and that older patients are more likely to experience delayed symptom progression.We suggest that patients and their families be counselled accordingly before surgery.Reported events: 1 patient experienced a pulmonary embolus after vp shunt placement.2 patients experienced a seizure after vp shunt placement.2 patients experienced a subdural or intracerebral hematoma after vp shunt placement with 1 requiring re-operation.2 patients experienced a hyponatremia after vp shunt placement.27 developed delayed deterioration in some or all of the three categories of symptoms, between 3 and 77 months postoperatively.Clinical findings in the 27 patients, who were felt by their treating surgeons to have a functioning shunt, are summarized as follows.Of note, only 2 patients with delayed symptomatic progression had isolated progression of cognitive symptoms; nearly all patients had progression of other symptoms (gait, urinary) as well.In 19 of the 27 patients, the medical record included specific clinical or imaging data that was interpreted by the treating surgeon as showing shunt function.9 patients had smaller ventricles than preoperatively, at the time of symptom progression.8 patients had unilateral or bilateral subdural hygromas not present on preop or initial postoperative imaging.1 patient had a shunt tap confirming good proximal and distal shunt function, and 1 patient underwent intraoperative exploration of the shunt, which confirmed good proximal and distal function.19 patients felt to have functioning shunts underwent attempts to improve their symptoms with further decreases of the shunt valve pressure setting at the time of delayed symptom progression, and had documentation in the medical record of symptoms before and after the adjustments.In 6 of these patients, symptoms improved for >30 days after one or more shunt valve pressure adjustments, but subsequently deteriorated further in all cases.New neurological diagnoses that were felt to explain at least part of the delayed symptom progression were made in 12 patients.Diagnoses included parkinson disease (4 patients), lewy body dementia (1 patient), post stroke dementia (1 patient), frontotemporal dementia (1 patient), cervical spinal stenosis (1 patient), lumbar spinal stenosis (1 patient), psychogenic gait disorder (1 patients), essential tremor with lower extremity involvement (1 patient), and poorly controlled diabetes with neuropathy (1 patient).1 of the 27 patients with delayed symptomatic progression was found on shunt tap to have a nonfunctioning shunt after his symptoms worsened 4 months after surgery, and his symptoms improved after shunt revision.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7997358
• MDR Text Key: 124812375
• Report Number: 2021898-2018-00509
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR