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

Model Number UNKNOWN-V

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Headache (1880); Hematoma (1884); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: 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.Sex: 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.Date of event: 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

Maya kommer, campbell & m.Canty.Prior endoscopic third ventriculostomy does not increase ventriculoperitoneal shunt failure rate.Child's nervous system (2019).Doi: 10.1007/s00381-019-04186-0.Abstract purpose: to determine whether prior endoscopic third ventriculostomy (etv) influences the failure rate of subsequently placed ventriculoperitoneal (vp) shunts.Methods: our institution¿s operative database and patient records were reviewed retrospectively to identify all paediatric patients who had undergone a first vp shunt or etv at our institution between january 2012 and december 2015.Data was analysed using the (b)(6) statistics.The literature on this topic to date was also reviewed.Results: eighty-six children were included in the study: 61 patients had a primary vp shunt inserted during the study period and 25 had a vp shunt inserted following failed etv.There was no significant difference in the underlying aetiology or age of the patients in each group.In the primary vp shunt group, 47.5%(29 patients) required shunt removal at an average of 274 days postinsertion (range 7 days to 3.4 years).The 1-year revision rate was 34.4%.In the shunt post-etv group, 48% (12 patients) required shunt removal at an average of 207 days post-insertion (range 2 days to 2.7 years).The 1-year revision rate was 36%.The most common reason for revision in both groups was blockage.Conclusions:we found no significant difference in failure rate or pattern between primarily inserted vp shunts and those inserted following an endoscopic third ventriculostomy.On the basis of this study and the small number of previously reported studies, we would advocate a trial of etv where feasible to allow a chance at shunt independence.Reported events: sixty-one patients underwent primary vp shunt insertion.Twenty-nine of the 61 patients (47.5%) required shunt removal in this group at an average of 274 days post-insertion (range 7 days to 3 years).The 1-year revision rate was 34.4%.Reasons for revision were blockage (nine patients), malposition/migration (six patients), infection (five patients), headache in three patients resulting in a change to a programmable valve, overdrainage in two patients (one patient developed a subdural haematoma), disconnection in two patients, one patient was bypassing csf and the reason for revision was unknown in one patient.Of the 61 patients who underwent primary vp shunt insertion in this literature article, 11 of the patients were identified to have the manufacturer's device, and 7 out of the 11 experienced the report events, but it is unclear whether the reported events were involved with the 7 patients that had the manufacturer's device.

• Brand Name: UNKNOWN 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: 8729425
• MDR Text Key: 149066008
• Report Number: 2021898-2019-00253
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2019

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 Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• 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: 3 YR