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

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Post Operative Wound Infection (2446)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.This value reflects the average age of the patients who underwent the csf shunting as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the csf shunting as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.The serial number was not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Sweid, a., daou, b.J., weinberg, j.H., starke, r.M., sergott, r.C., schaefer, j., hauge, j., elizabeth, c., chalouhi, n., gooch, r., herial, n., zarzour, h., jabbour, p., rosenwasser, r.H., & tjoumakaris, s.(2021).Experience with ventriculoperitoneal and lumboperitoneal shunting for the treatment of idiopathic intracranial hypertension: a single institution series.Operative neurosurgery, 21(2), 57¿62.Https://doi.Org/10.1093/ons/opab106.Summary background: csf shunting is among the most widely utilized interventions in patients with idiopathic intracranial hypertension (iih).Ventriculoperitoneal shunting (vps) and lumboperitoneal shunting (lps) are 2 possible treatment modalities.Objective: to evaluate and compare complications, malfunction, infection, and revision rates associated with vps compared to lps.Methods: electronic medical records were reviewed to identify baseline and treatment characteristics for patients diagnosed with iih treated with vps or lps.Results: a total of 163 patients treated with either vps (74.2%) or lps (25.8%) were identified.The mean follow-up was 35mo.Shunt revision was required in 40.9% of patients.There was a nonsignificant higher rate of revision with lps (52.4%) than vps (36.4%, p=.07).In multivariate analysis, increasing patient age was associated with higher odds of shunt revision (p =.04).Lps had higher odds of shunt revision, yet this association was not significant (p =.06).Shunt malfunction was the main indication for revision occurring in 32.7%, with a significantly higher rate with lps than vps (p =.03).In total, 15 patients had shunt infection (9.4% vps vs 12.2% lps p=.50).The only significant predictor of procedural infection was the increasing number of revisions (p =.02).Conclusion: the incidence of shunt revision was 40.9%, with increasing patient age as the sole predictor of shunt revision.The incidence of shunt malfunction was significantly higher in patients undergoing lps, while there was no significant difference in the incidence of shunt infection between the 2 modalities.Reported events: a hundred and sixty-three patients underwent csf shunting to address idiopathic intracranial hypertension (iih).Sixty-five of these patients had to undergo 110 revisions, with 71 revisions being with vps, which was being performed with a navigation system.Thirty-four shunt malfunctions were sited, with thirty-three of them being due to malposition, displacement, and migration.One of these shunt malfunctions were proximal and thirty-two of them were distal.Nine revisions were due to obstruction, with three of them being proximal and six were distal.One revision was due to overdrainage.Six revision were due to valve dysfunction.Twelve revisions were due to unspecified reasons, but four were proximal and eight were distal.Ten revision were due to infection, where one shunt was proximal and nine were distal.Twenty-four cases had valve adjustment.There was one case of peripheral cn vii palsy, one case of wound infection, and one case of intracerebral hemorrhage.The article stated that an independent predictor or shunt revision was increasing patient age.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12916766
• MDR Text Key: 286640969
• Report Number: 1723170-2021-02793
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/24/2021
• 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): Other; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female