MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT, OPEN TIP, 84 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 44406

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return as it remains implanted.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.All catheters are 100% inspected at the time of manufacture.

Event Description

It was reported to medtronic neurosurgery that the device was found to be coiled inside the spinal canal.According to the report, the patient experienced numbness in the lower limbs.

Manufacturer Narrative

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

• Brand Name: LUMBAR CATHETER KIT, OPEN TIP, 84 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: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 5763731
• MDR Text Key: 48613818
• Report Number: 2021898-2016-00222
• 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,Followup
• Report Date: 06/01/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 44406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: 06/01/2016
• Supplement Dates FDA Received: 09/23/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other