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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

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MEDTRONIC, INC. DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5392
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the external pulse generator (epg) had a broken connector.The status of the epg is unknown.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the output connector was broken.It was noted that the hanger was broken.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the epg was returned.
 
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Brand Name
DUAL CHAMBER TEMPORARY PACEMAKER
Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9369261
MDR Text Key167817247
Report Number2182208-2019-02109
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5392
Device Catalogue Number5392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/05/2020
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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