MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC

Model Number 9734056

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field and the cable was replaced which resolved the failure. Codes 10, 4203 and 4307 are applicable. The cable was returned and analyzed. The cable jacket had separated at the lemo connector exposing the shield wire but no bare conductors. A continuity test also revealed an open at pin 4 of the usb cable. Codes 10, 4203 and 4307 are applicable. Other relevant device(s) are: product id: 9 733597, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a cranial resection. It was reported that the coating peeled off. There was no hindrance in use. There was no delay to the case. No impact on patient outcome.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10344847
• MDR Text Key: 201045265
• Report Number: 1723170-2020-02064
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse