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

Model Number UNKNOWN-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

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 bowel injury after vp shunt placement.

• Brand Name: UNKNOWN CATHETER
• 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: 8015706
• MDR Text Key: 125347726
• Report Number: 2021898-2018-00515
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/29/2018
• 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): Other
• Patient Age: 75 YR