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

Model Number	43522
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Dysphasia (2195); Loss of consciousness (2418); Ambulation or Postural Difficulties (2544); Lethargy (2560); No Code Available (3191)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was diagnosed with hydrocephalus in or about (b)(6) 2018.After going various options, their medical team recommended surgery and the insertion of a shunt to drain fluid from their head.The surgery took place the morning of (b)(6) 2019.The procedure took approximately 2 hours, during which a ventricle and peritoneal catheter from the manufacturer were inserted in accordance with standard practice and procedure.While in post-op care the same day as the surgery, the patient became lethargic and lost consciousness.They were subsequently taken for a ct scan where it was discovered that the shunt was draining fluid far too rapidly.As a result, they were rushed into a further surgery where the shunt was clamped off to prevent further drainage, however, that was not before the patient suffered what appeared to be significant brain damage including, but not limited to, an inability to walk, paralysis of their vocal cords, an inability to eat among other things.

• Brand Name: PERITONEAL CATHETER, STANDARD, 90 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9628335
• Report Number: 2021898-2020-00045
• Device Sequence Number: 2383092
• Product Code: JXG
• UDI-Device Identifier: 00643169497122
• UDI-Public: 00643169497122
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 43522
• Device Catalogue Number: 43522
• Device Lot Number: E61550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 77 YR