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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Headache (1880); Vomiting (2144); Cognitive Changes (2551); Abdominal Distention (2601); No Code Available (3191)
Event Date 12/10/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Yasuhiro koide, takaaki osako, masahiro kameda, hiromi ihoriya, hirotsugu yamamoto, noritomo fujisaki, toshiyuki aokage, tetsuya yumoto, isao date, hiromichi naito and atsunori nakao.Huge abdominal cerebrospinal fluid pseudocyst following ventriculoperitoneal shunt: a case report.Journal of medical case reports (2019).Doi: 10.1186/s13256-019-2308-0 abstract introduction: abdominal pseudocysts comprising cerebrospinal fluid are an uncommon but significant complication in patients with ven triculoperitoneal shunt.We present a successfully treated 12-year-old boy with a history of ventriculoperitoneal shunting and a huge abdominal cerebrospinal fluid pseudocyst.Case presentation: a12-year-old japanese boy presented with a deteriorated consciousness and a palpable and elastic large lower abdominal mass.Computed tomography of his abdomen demonstrated a collection of homogenous l ow-density fluid near the catheter tip of the ventriculoperitoneal shunt.Cerebral computed tomography revealed an increased ventricular size.Based on the clinical diagnosis of abdominal pseudocyst, the peritoneal shunt catheter was secured and divided into two parts by cutting it on the chest; then, the proximal side of the peritoneal shunt catheter was externalized for extraventricular drai nage.The cyst was percutaneously aspirated with ultrasound guidance, and the distal side of the peritoneal shunt catheter was removed.The distal side of the peritoneal shunt catheter was reinserted in another position into his abdomen after 3-week extraventricular drainage management.Conclusion: emergency physicians should know about this potential complication as an important differential diagnosis resulting from acute abdominal complaints in patients with ventriculoperitoneal shunts.Reported event.A 12-year-old japanese boy presented with complaints of disturbance of consciousness and vomiting associated with increasing abdominal distension starting 3 days prior to presentation.He complained of headache and appetite loss for 7 days.His previous medical history included repair of myelomeningocele on the day of his birth; subsequently, a vp shunt was placed for congenital hydrocephalus associated with spina bifida when he was 10-days old.Thereafter, he underwent several subsequent abdominal surgeries for reinsertion of the shunt catheter and was followed up every 6 months without medication.A physical examination revealed a deteriorated consciousness (glasgow coma scale score of e1v2m4) and a large palpable elastic mass in his lower abdomen.His vital signs were stable (blood pressure 124/76 mmhg, heart rate 88 beats/minute, body temperature 36.8 °c).His pupil sizes were 3mm in each eye with rapid light reflex.Laboratory tests results revealed an increased white blood cell count of 9910/¿l (3300¿8600 /¿l) and a c-reactive protein level of 0.54 mg/dl (<(><<)> 0.15 mg/dl).Liver and kidney functions were normal with normal serum electrolytes.Serum ammonia level was 34 ¿g/dl (30¿80 ¿g/dl).Urine analysis results were unremarkable.An abdominal ultrasound confirmed a large collection of homogeneous encysted fluid encapsulating the tip of the shunt catheter.Abdominal radiography showed the vp shunt catheter and the presence of a soft tissue mass in his upper abdomen.Cranial computed tomography (ct) showed bilateral ventricular dilation and effacement of sulci.An abdominal ct scan demonstrated a 11 cm × 8 cm× 7 cm collection of homogenous low-density fluid adjacent to the catheter tip of the vp shunt.As abdominal pseudocyst associated with shunt malfunction was highly suspected as a diagnosis, the proximal side of the peritoneal shunt catheter (strata® 0.5, nsc¿ valve, medtronic, inc., minneapolis, mn, usa) was distally externalized for extraventricular drainage management by neurosurgery.Subsequently, the cystic mass was punctured through the abdominal wall and 900 ml of clear fluid was drained.Culture of the drained intracystic fluid was negative for microorganisms, with protein 36 iu/l and glucose 71mg/dl.The leukocyte and erythrocyte counts were 0 and 2/¿l, respectively.The distal side of the peritoneal shunt catheter was removed from his abdominal cavity.Prophylactic cefazolin sodium 3 grams/ day was administered for 3 days postoperatively.A followup brain ct taken 3 days postoperatively revealed no increase in ventricular size.The shunt catheter was reinserted to another position in his abdomen 3 weeks later.He fully recovered with no further complications.See attached literature article.
 
Manufacturer Narrative
Additional review indicated the event captured in this report pertained to the event previously reported under regulatory report 2021898-2020-00014.Any further information for the event will be reported under the referenced report.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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Brand Name
UNKNOWN CATHETER
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
MDR Report Key10154687
MDR Text Key198690207
Report Number2021898-2020-00169
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN-C
Device Catalogue NumberUNKNOWN-C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age12 YR
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