MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NDI PASSIVE SPHERE

Model Number 8801075

Device Problem Device Unsafe to Use in Environment (2918)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

No procode, common device name and/or 510k provided as this device is not released for distribution in the united states.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that pre-operatively, it was found that there was a black hair adhered in the packet seal.There was no patient associated with this event.

Manufacturer Narrative

The part was returned to the manufacturer for analysis and the reported issue was confirmed.The sealed package of five had a hair sealed inside and poking outside at the edge of the package.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NDI PASSIVE SPHERE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8688748
• MDR Text Key: 147894001
• Report Number: 1723170-2019-03192
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 20805832070030
• UDI-Public: 20805832070030
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/04/2020
• Device Model Number: 8801075
• Device Catalogue Number: 8801075
• Device Lot Number: 1812191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2018
• 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