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

Model Number 44421

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the lumbar peritioneal (lp) shunt procedure was performed in the 4th week of (b)(6) 2017, a lumbar catheter could not be inserted smoothly.Then, the lumbar catheter was mistakenly pulled out in the opposite direction while the puncture needle had been inserted.As a result, the tip of the lumbar catheter was scooped out, and the detached fragments have been drifting in the spinal cavity.It was noted that the tip of the lumbar catheter was detached as it was scooped out by the puncture needle.While some fragments were removed out of the patient's body, some have been drifting in the spinal cavity.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• 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: 7060875
• MDR Text Key: 93366666
• Report Number: 2021898-2017-00593
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44421
• Device Catalogue Number: 44421
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• 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