MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number UNK_NAV_SYS

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

Patient Problems Nerve Damage (1979); Paresis (1998); Visual Impairment (2138)

Event Date 06/08/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the reported events.Patient gender is the majority value of patients in the reported events.Patient weight not available from the site.Event date is the accepted date of the publication.D4) device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: pietro spennato, carmela chiaramonte, carmela russo, nicola onorini, guiseppe mirone, federica mazio, giulana di martino, raffaele stefano parlato, guiseppe cinalli.Subtemporal transtentorial approach in mesencephalic and perimesencephalic lesions in children - a series of 20 patients.Operative neurosurgery 18:349¿362, 2020.Doi: 10.1093/ons/opz254 abstract: background: midbrain and surrounding areas are among the most difficult regions to surgically approach in neurosurgery.The subtemporal approach is awell-known neurosurgical approach that is rarely described in children.Objective: to assess the feasibility, advantages, and disadvantages of subtemporal approach in children.Methods: a total of 20 pediatric patients with intra-axial tumors involving the lateral midbrain or superior cerebellar peduncle or with extra-axial tumors in themiddle incisural space/meckel cave underwent subtemporal transtentorial approaches with the aim to remove (16 cases) or biopsy (4 cases) their lesions.These cases were retrospectively reviewed and the surgical approach described.Results: total resection was achieved in 11 patients.In the 4 patients who underwent biopsies, a diagnosis was obtained.A total of 5 patients presented non-neoplastic lesions (dermoid tumors or cavernomas).A total of 9 patients harbored low-grade tumors and 6 high-grade tumors.Patients with low-grade tumors and non-neoplastic lesions are all alive with no evidence of disease or stable residue.Four patients affected by high grade tumors died.No patient suffered permanent neurological deficits related to the surgical approach.Three patients presented temporary neurological deficits following the procedure: one case of strabismus, one case of aphasia and hemiparesis, secondary to delayed, transient thrombosis of the labbé vein, and 1 case of trigeminal neuralgia.Conclusion: the subtemporal approach represents a feasible approach for mesencephalic and perimesencephalic lesions in children.It provides an ample and direct access, with excellent outcomes and acceptable postoperative morbidity.Reported events: (b)(6) yr old male experienced post-operative trigeminal neuralgia which lasted for sixth months and was managed with carbamazepine (b)(6) yr old male experienced post-operative transient diplopia (related to the dysfunction of the right iv cranial nerve) (b)(6) yr female experience hemiparesis and aphasis on the third post-operative day.It was reported that the patient was managed with low-molecular weight heparin.Symptoms were resolved two weeks later.The labbe was re-canalized on magnetic resonance imaging (mri) and performed two months later.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10995701
• MDR Text Key: 223065102
• Report Number: 1723170-2020-03252
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050438
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR