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

Model Number UNKNOWN-S

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

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Seroma (2069)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Johan gasslander, nina sundström, anders eklund, lars-owe d.Koskinen, and jan malm.Risk factors for developing subdural hematoma: a registry-based study in 1457 patients with shunted idiopathic normal pressure hydrocephalus.Journal of neurosurgery 134 (2021).Doi: 10.3171/2019.10.Jns191223.Objective subdural hematomas and hygromas (sdhs) are common complications in idiopathic normal pressure hydrocephalus (inph) patient s with shunts.In this registry-based study, patients with shunted inph were screened nationwide to identify perioperative variables that may increase the risk of sdh.Methods the (b)(6) hydrocephalus quality registry was reviewed for inph patients who had undergone shunt surgery in (b)(6) in 2004¿2014.Potential risk factors for sdh were recorded preoperatively and 3 months after surgery.Drug prescriptions were identified from a national pharmacy database.Patients who developed sdhs were compared with those without sdhs.Results the study population consisted of 1457 patients, 152 (10.4%) of whom developed an sdh.Men developed an sdh more often than women (or 2.084, 95% ci 1.421¿3.058, p < 0.001).Patients on platelet aggregation inhibitors developed an sdh more often than those who were not (or 1.733, 95% ci 1.236¿2.431, p = 0.001).At surgery, shunt opening pressures had been set 5.9 mm h2o lower in the sdh group than in the no-sdh group (109.6 ± 24.1 vs 115.5 ± 25.4 mm h2o, respectively, p = 0.009).Anti siphoning devices (asds) were used in 892 patients but did not prevent sdh.Mean opening pressures at surgery and the follow-up were lower with shunts with an asd, without causing more sdhs.No other differences were seen between the groups.Conclusions inph patients in this study were diagnosed and operated on in routine practice; thus, the results represent everyday care.Male sex, antiplatelet medication, and a lower opening pressure at surgery were risk factors for sdh.Physical status and comorbidity were not.Asd did not prevent sdh, but a shunt with an asd allowed a lower opening pressure without causing more sdhs.Reported events.- in 152 (10.4%) patients, a first-ever sdh was observed (sdh group) during the study period.For the patients having an sdh, 9.9% were conservatively treated (no treatment), 56.6% were treated with opening pressure adjustment, and 33.6% underwent surgery.53.6 % of the sdh patients were implanted with a strata valve.

• Brand Name: UNKNOWN STRATA 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11802596
• MDR Text Key: 263549318
• Report Number: 2021898-2021-00106
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 04/28/2021
• 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): Hospitalization; Required Intervention