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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
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MEDTRONIC, INC; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE Back to Search Results
Model Number MDT-UNKNOWN
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Tingling (2171)
Event Date 11/07/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient had experienced a tingling sensation in their left chest and soreness at the device site.The device also appeared to be a bit more lateral than in the past and was rubbing against the patient's muscle.No further information could be obtained and the device remains in use.The patient is a participant in the (b)(6) clinical study.No further patient complications have been reported as a result of this event.
 
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Type of Device
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC, INC
mounds view
Manufacturer (Section G)
MEDTRONIC, INC
mounds view
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7255338
MDR Text Key99918647
Report Number2182208-2018-00129
Device Sequence Number1
Product Code DXY
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 Physician
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMDT-UNKNOWN
Device Catalogue NumberMDT-UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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