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 Cerebrospinal Fluid Leakage (1772); Cyst(s) (1800); Unspecified Infection (1930)

Event Date 08/22/2014

Event Type  Injury  

Manufacturer Narrative

Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Please note that this weight is the average weight of the patients reported in the article, as the actual weight of patients involved was not provided.Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Joanna y.Wang, b.A.,anubhav g.Amin, m.D.,george i.Jallo, m.D., and edward s.Ahn, m.D.Ventricular reservoir versus ventriculosubgaleal shunt for posthemorrhagic hydrocephalus in preterm infants: infection risks and ventriculoperitoneal shunt rate.Journal of pediatrics 14 (2014).Doi: 10.3171/2014.7.Peds13552 object.The most common neurosurgical condition observed in preterm infants is intraventricular hemorrhage (ivh), which often results in posthemorrhagic hydrocephalus (phh).These conditions portend an unfavorable prognosis; therefore, the potential for poor neuro developmental outcomes necessitates a better understanding of the comparative effectiveness of 2 temporary devices commonly used before the permanent insertion of a ventriculoperitoneal (vp) shunt: the ventricular reservoir and the ventriculosubgaleal shunt (vsgs).Methods.The authors analyzed retrospectively collected information for 90 patients with ivh and phh who were treated with insertion of a ventricular reservoir (n = 44) or vsgs (n = 46) at their institution over a 14-year period.Results.The mean gestational age and weight at device insertion were lower for vsgs patients (30.1 ± 1.9 weeks, 1.12 ± 0.31 kg) than for reservoir patients (31.8 ± 2.9 weeks, 1.33 ± 0.37 kg; p = 0.002 and p = 0.004, respectively).Ventricular reservoir insertion was predictive of more csf taps prior to vp shunt placement compared with vsgs placement (10 ± 8.7 taps vs 1.6 ± 1.7 taps, p <(><<)> 0.001).Vsgs patients experienced a longer time interval prior to vp shunt placement than reservoir patients (80.8 ± 67.5 days vs 48.8 ± 26.4 days, p = 0.012), which corresponded to vsgs patients gaining more weight by the time of shunt placement than reservoir patients (3.31 ± 2.0 kg vs 2.42 ± 0.63 kg, p = 0.016).Reservoir patients demonstrated a trend toward more positive csf cultures compared with vsgs patients (n = 9 [20.5%] vs n = 5 [10.9%], p = 0.21).There were no significant differences in the rates of overt device infection requiring removal (reservoir, 6.8%; vsgs, 6.5%), vp shunt insertion (reservoir, 77.3%; vsgs, 76.1%), or early vp shunt infection (reservoir, 11.4%; vsgs, 13.0%) between the 2 cohorts.Conclusions.Although the rates of vp shunt requirement and device infection were similar between patients treated with the reservoir versus the vsgs, vsgs patients were significantly older and had achieved greater weights at the time of vp shunt insertion.The authors¿ results suggest that the vsgs requires less labor-intensive management by ventricular tapping; the vsgs patients also attained higher weights and more optimal surgical candidacy at the time of vp shunt insertion.The potential differences in long-term developmental and neurological outcomes between vsgs and reservoir placement warrant further study.Reported events.Reservoir patients experienced higher, though not statistically significant, rates of csf culture positivity, with 9 reservoir patients (20.5%) compared with 5 vsgs patients (10.9%) (p = 0.21) (table 3).Csf culture positivity was associated with higher rates of tapping in both groups; in reservoir patients, those who developed positive cultures experienced on average 19.3 ± 3.6 taps compared with 7.3 ± 0.9 taps in patients who did not develop positive cultures (p <(><<)> 0.001).In vsgs patients, those with positive cultures underwent 4.0 ± 0.3 taps compared with 1.2 ± 0.2 taps (p <(><<)> 0.001).Upon detection of device infection, the patients were treated with intravenous antibiotics with or without immediate device removal.The rates of device infection treated by immediate removal were comparable between the 2 groups (reservoir, n = 3 [6.8%]; vsgs, n = 3 [6.5%]; p = 0.96).During follow-up, 4 vsgs patients (8.7%) developed porencephalic cysts along the ventricular catheter.These cysts resolved for those patients who underwent vsgs removal and insertion of a vp shunt.None of these patients developed clinically significant signs or symptoms related to the porencephalic cysts.Of the vsgs patients, 3 patients (6.5%) developed csf leaks.These patients were managed with device removal and ventricular tapping; 1 patient underwent vsgs replacement and 2 patients eventually underwent vp shunt placement.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8106555
• MDR Text Key: 128433672
• Report Number: 2021898-2018-00539
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• 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: 11/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 1