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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
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MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) Back to Search Results
Model Number 5487
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
Product analysis: manufacturer's analysis was unable to confirm the customer comment that the cable would not stay connected.The cable passed all incoming testing.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cable would not stay connected.The cable was returned for analysis.There was no patient involvement.
 
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Brand Name
NA
Type of Device
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7480420
MDR Text Key107158624
Report Number2182208-2018-00826
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5487
Device Catalogue Number5487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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