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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN DELTA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-A
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 sundstr¿m, 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 swedish hydrocephalus quality registry was reviewed for inph patients who had undergone shunt surgery in (b)(6) in 20042014. 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. 4213. 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. 2362. 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). Antisiphoning 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. 1. 3% of the sdh patients were implanted with a delta valve.
 
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Brand NameUNKNOWN DELTA VALVE/SHUNT
Type of DeviceSHUNT, 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 Key11802619
MDR Text Key262206620
Report Number2021898-2021-00107
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
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 Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-A
Device Catalogue NumberUNKNOWN-A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
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