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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85; LEAD
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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85; LEAD Back to Search Results
Model Number 401180
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
Event or Problem Description
During routine follow up, lv lead dislodgement has been diagnosed.X-ray, ecg and lab test were done for diagnostic reasons.The patient was hospitalized and lv lead replacement was done (b)(6) 2019.
 
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Brand Name
SENTUS PROMRI OTW QP S-85
Common Device Name
LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key8992369
Report Number1028232-2019-03954
Device Sequence Number1825622
Product Code OJX
UDI-Device Identifier04035479138417
UDI-Public04035479138417
Combination Product (Y/N)N
PMA/510(K) Number
P070008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/30/2020
Device Model Number401180
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/09/2019
Initial Report FDA Received Date09/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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