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

Model Number UNKNOWN-V

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

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Unspecified Infection (1930)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Jong han gill, hyun ho choi, shin heon lee, kyoung min jang, taek kyun nam, yong sook park, and jeong taik kwon.Comparison of postoperative complications between simultaneous and staged surgery in cranioplasty and ventriculoperitoneal shunt placement after decompressive craniectomy.Korean j neurotrauma 17 (2021).Doi: 10.13004/kjnt.2021.17.E20.Abstract objective: cranioplasty (cp) and ventriculoperitoneal shunt (vps) are required procedures following decompressive craniectomy (dc) for craniofacial protection and to prevent hydrocephalus.This study assessed the safety and efficacy of simultaneous operation with cp and vps after dc, and determined the preoperative risk factors for postoperative complications.Methods: between january 2009 and december 2019, 81 patients underwent cp and vps in simultaneous or staged operations following dc.Cumulative medical records and radiologic data were analyzed using univariate analysis to identify factors predisposing patients to complications after cp and vps.Results: cp and vps were performed as simultaneous or staged operations in 18 (22.2%) and 63 (77.8%) patients, respectively.The overall postoperative complication rate was 16.0% (13/81).Patients who underwent simultaneous cp and vps were significantly more likely to experience complications when compared with patients who underwent staged operations (33.3% vs.9.6%, p < 0.01).Univariate analysis revealed that simultaneous cp and vps surgery was the only significant predictor of postoperative complications (p=0.031).Conclusion: this study provided detailed data on surgical timing and complications for cp and vps after dc.We showed that simultaneous procedures were a significant risk factor for postoperative complications.Reported events: the overall postoperative complication rate was (b)(4) (13/81).Intracranial abscesses (epidural and brain abscesses) developed in 7 patients (8.6%) and mechanical infection in 2 (2.5%).Intracranial hemorrhage (epidural and intraventricular hemorrhage) developed in 3 patients (3.7%) and pneumocephalus in one patient.9 patients received the strata adjustment valve and 7 patients received the csf-flow control valve; however, the article did not indicated if the events occurred with these devices.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12957309
• MDR Text Key: 287122542
• Report Number: 2021898-2021-00214
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/29/2021
• 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