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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC Back to Search Results
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.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceINSTRUMENT, 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 Key10344847
MDR Text Key201045265
Report Number1723170-2020-02064
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
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 Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? No
Date Returned to Manufacturer07/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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