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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MAGNET, TEST, PACEMAKER

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MEDTRONIC, INC. MAGNET, TEST, PACEMAKER Back to Search Results
Model Number MDT-SLITTER
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure the physician was slitting the catheter and the slitter slipped off. It was also reported the physician had difficulty affixing to start slitting again and this process the right ventricular (rv) lead insulation was damaged. It was noted the lead numbers were stable despite the insulation breach. The lead was removed and replaced. No patient complications have been reported as a result of this event.
 
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Type of DeviceMAGNET, TEST, PACEMAKER
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8498655
MDR Text Key141911366
Report Number2182208-2019-00674
Device Sequence Number1
Product Code DTG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDT-SLITTER
Device Catalogue NumberMDT-SLITTER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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