MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 43103

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that prior to the implant of the shunt, the patient experienced syncope and was hospitalized in early (b)(6) 2012.A few days after the syncope, they underwent tumor resection with a suboccipital approach.The patient had a ventriculoatrial shunt installed by the end of (b)(6) 2012.A few years later, in late (b)(6) 2016, the patient¿s brain tumor recurred.They underwent tumor resection in early (b)(6) and the pressure level (pl) setting of the valve was set to 0.5.The patient experienced vomiting, unstable walking, and was unresponsive in (b)(6) 2017.The patient was admitted with the pl setting still at 0.5.It was stated that 200-300 ml of cerebrospinal fluid was drained from the patient and their symptoms improved.In late (b)(6) , the patient had exploratory surgery and after the operation was better, however would soon regress.It was noted the patient repeatedly had mris done following surgery and could not reach the same drainage effect as experienced prior to the mri.The shunt was removed and replaced.

Manufacturer Narrative

Approximately 32 cm of the peritoneal catheter was returned.The returned catheter was patent and met the requirements for leak testing.There was proteinaceous debris observed within the interior and exterior of the catheter.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ all catheters are 100% inspected at the time of manufacture.Upon review of the additional information received, it was determined that eval code conclusion 92 no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care provider (hcp) via a manufacturer representative (rep).It was confirmed that the valve settings were changed after the mri.

• Brand Name: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM
• 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: 7064342
• MDR Text Key: 93113462
• Report Number: 2021898-2017-00611
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K792005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: D21186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24 YR