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

Model Number UNKNOWN-C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Headache (1880); Incontinence (1928); Nausea (1970); Confusion/ Disorientation (2553)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Eva nabbanja, john douglas pickard, afroditi despina lalou, zofia helena czosnyka.Use of csf infusion studies to unblock occluded hydrocephalus ventricular shunt catheters: a preliminary report of two patients.British medical journal (2018).Doi:10.1136/bcr-2017-223861.Summary two patients with ventriculoperitoneal shunts presented with symptoms of raised intracranial pressure indicative of possible shunt malfunction.During investigation, to eliminate this possibility, cerebral spinal fluid infusion studies were performed, which indicated proximal occlusion of the shunts in both cases.Retrograde flush of the ventricular catheter was performed during temporary compression of the siphon-control device, a manoeuvre which blocks distal flow.After the use of this technique, both patients¿ symptoms improved and they have remained symptom-free for over 2 years.This case report validates the role that infusion studies can play in clearing a blocked ventricular catheter shunt.Reported events.1.A 30-year-old woman presented to the emergency departments at a district general hospital with a 48-hour history of drowsiness, confusion and episodes of incontinence.Her shunt with a medium pressure non-adjustable valve had been inserted 15 years before for aqueduct stenosis.Her glasgow coma scale (gcs) was 14/15 (e:4, v:4, m:6).No nausea or vomiting was present and her inflammatory markers were low.The x-ray series showed that there was no kink or discontinuity with the shunt tip in the lower abdomen.A ct head scan without contrast showed a well-positioned right parietal ventricular catheter.Triventricular hydrocephalus with some temporal periventricular lucency was shown suggestive of a blocked vp shunt.Under aseptic conditions and with informed consent, an infusion study was performed.Two 25g butterfly needles were inserted into the prechamber of the shunt valve.One needle was used for recording pressure and the other needle for infusion of ringer¿s lactate solution.The opening pressure was normal (8.5 mm hg) but the pulse waveform was disproportionally small and barely detectable.Ringer¿s lactate solution was infused at 1.5 ml/min.6¿8 after starting the infusion, the pulse amplitude further decreased.The plateau icp was reached almost immediately at 15.4 mm hg.These results indicated that the shunt was draining distally but the ventricular catheter was partially blocked, probably by choroid plexus ingrowing into a lumen of the catheter.At the end of the infusion test, 2 ml of ringer¿s lactate solution was injected into the shunt prechamber of the patient while distal flow was blocked by temporary compression of the occlusion chamber that is distal to the valve.After the flush, the patient's icp increased reaching plateau of 15 mm hg and the pulse waveform of undisturbed shape and magnitude reappeared.The patient's gcs returned to normal and she was subsequently discharged home.At her 3-month follow-up appointment, she was symptom-free.A repeat ct head scan at 4 months revealed resolution of hydrocephalus.2.A 27-year-old man who was referred by a general practitioner with a 7-day history of headaches and nausea characteristic of raised intracranial pressure (icp).His shunt with a strata adjustable valve had been inserted 2 years before for congenital hydrocephalus.Ct head showed no increase in the size of ventricles.It is not unusual for patients with vp shunt malfunction to lack radiographic evidence of ventricular dilatation on imaging.An infusion study performed revealed that the baseline pressure was low and non-pulsatile.After the start of infusion, icp increased to 6 mm hg and pulsations appeared.Icp stabilised at 10 mm hg showing low resistance to distal flow.These results indicated intermittent blockage of the ventricular catheter.At the end of the infusion test, 2 ml of ringer¿s lactate solution was injected into the shunt prechamber of the patient while distal flow was blocked by temporary compression of the occlusion chamber that is distal to the valve.After the flush, the patient's icp increased reaching plateau of 8 mm hg and the pulse waveform of undisturbed shape and magnitude reappeared.The patient was reviewed in the clinic 3 months after treatment and was found to be free of the symptoms of raised icp.

• Brand Name: UNKNOWN CATHETER
• 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: 8183284
• MDR Text Key: 131386059
• Report Number: 2021898-2018-00571
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/20/2018
• 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