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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSYPKA MEDICAL GMBH MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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OSYPKA MEDICAL GMBH MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5391
Device Problem No Pacing (3268)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
Event Type  malfunction  
Event Description
It was reported that the external pulse generator (epg) was unable to provide pacing support, the epg was set to the highest output but there was no pacing available.The epg is expected to be returned for service.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Manufacturer is waiting for returned device for evaluation or report from the distributors service center test results.
 
Event Description
It was reported that the external pulse generator (epg) was unable to provide pacing support, the epg was set to the highest output but there was no pacing available.The epg is expected to be returned for service.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
It could be confirmed that the pacemaker did not have any defect which could have caused the reported pacing problem.Possible root causes others than the pacemaker would be: - contact problems between lead and tissue - contact problems between lead and patient cable or adapter cable - defect adapter cable - inappropriate pacemaker parameter setting (eg.Stimulation amplitude set lower then capture threshold and stimulation was ineffective).
 
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Brand Name
MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER
Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
OSYPKA MEDICAL GMBH
albert-einstein-strasse 3
berlin, berlin 12489
GM  12489
Manufacturer (Section G)
OSYPKA MEDICAL GMBH
albert-einstein-strasse 3
berlin, berlin 12489
GM   12489
Manufacturer Contact
thilo thuemecke
albert-einstein-strasse 3
berlin, berlin 12489
GM   12489
MDR Report Key15300474
MDR Text Key304200561
Report Number9681449-2022-00003
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K033130
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5391
Device Catalogue Number5391
Is the Reporter a Health Professional? No
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Reuse
Patient Sequence Number1
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