MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	44421
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
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 when the lumbar catheter was ligated to address overdrainage of cerebrospinal fluid (csf), the lumbar catheter tore.It was stated the lumbar catheter and valve were replaced.
Additional Manufacturer Narrative
Additional review indicated the event captured in this report pertained to the event previously reported under regulatory report 2021898-2018-00266.Any further information for the event will be reported under the referenced report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7673931
• Report Number: 2021898-2018-00325
• Device Sequence Number: 1370449
• Product Code: JXG
• UDI-Device Identifier: 00643169010789
• UDI-Public: 00643169010789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 07/31/2018
• Device Model Number: 44421
• Device Catalogue Number: 44421
• Device Lot Number: D44700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/08/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/04/2018
• 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