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

Model Number UNKNOWN-V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Hemorrhage, Intraventricular (1892); Unspecified Infection (1930); Complaint, Ill-Defined (2331); Hydrocephalus (3272)

Event Date 07/01/2012

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.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 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

Lin jian, sheng hang-song, lin zheng-lang, yu li-sheng, wang heng, zhang nu.Implantation of ommaya reservoir in extremely low weight premature infants with posthemorrhagic hydrocephalus: a cautious option.Childs nervous system 28 (2012).Doi 10.1007/s00381-012-1847-0 abstract: objective this study aims to evaluate effects and complications of the implantation of ommaya reservoir in premature infants with posthemorrhagic hydrocephalus (phh).Methods: the effects and complications of the implantation of ommaya reservoir in seven premature infants with phh were retrospectively analyzed.Intracapsular puncture of the reservoir was performed for draining cerebrospinal fluid.Results: seven extremely low-weight premature infants with phh (birthweight less than 1,000 g) were treated with the placement of an ommaya reservoir.Ommaya reservoirs in five infants were removed, but were retained in two infants.Two premature infants had to undergo ventriculoperitoneal (vp) shunt.Postsurgical major complications (including skin dehiscence, cerebrospinal fluid (csf) infection, ventricular hemorrhage, and csf leak) occurred in 57 % of all patients.Three infants of skin dehiscence and csf leak occurred.Two infants of csf infection occurred, as well as one clinically significant secondary hemorrhage.Six infants survived, and one died.Conclusion: the implantation of ommaya reservoir is a cautious option of treating low-weight premature infants with phh because of a relatively high complication rate.However, vp shunt surgery may be avoided in some infants.Reported events: a (b)(6) premature infant experienced a cerebrospinal fluid (csf) leak and skin dehiscence that occurred after implantation of the ommaya reservoir.The infant developed a csf infection, and the reservoir had to be removed.The parents of the infant refused to perform an external csf drainage.Treatment of the infant included drugs that control csf infection and decrease csf production.The infant survived with giant ventricle, eventually.A (b)(6) premature infant experienced a cerebrospinal fluid (csf) leak and skin dehiscence that occurred after implantation of the ommaya reservoir.The infant developed a csf infection after skin dehiscence in the wound site.The scalp was closed using 4.0 prolene sutures again, and the effusion was drained.A (b)(6) premature infant suffered from a secondary ventricular hemorrhage 2 days after surgery.The implanted reservoir was clogged and had to be washed with saline for proper functioning.Unfortunately, the infant ultimately died of complications unrelated to the reservoir.A (b)(6) premature infant experienced a cerebrospinal fluid (csf) leak and skin dehiscence that occurred after implantation of the ommaya reservoir.This infant also experienced a decrease in ventricular size after draining csf, but ct image showed a dilated ventricle after stopping draining csf.It was noted this infant had developed progressive hydrocephalus.After 10 days of vp shunt and removing ommaya reservoir, ct image showed a decreasing ventricle and shrunken bone suture.A (b)(6) premature infant developed progressive hydrocephalus.The reservoir was removed, and a vp shunt was implanted.

• 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: 8105855
• MDR Text Key: 128409084
• Report Number: 2021898-2018-00538
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 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
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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 Age: 19 DA
• Patient Weight: 1