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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-85/49; LV LEAD

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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85/49; LV LEAD Back to Search Results
Model Number 406082
Device Problem Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2022
Event Type  malfunction  
Event Description
It was reported that the lv lead conductor broke for all polarities due to noise interruption.(b)(6) 2022, lead was explanted and replaced.
 
Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis revealed that all wires of the conductor coil were found fractured 42 cm distal to the is4 connector pin.The above mentioned damage most likely resulted from a tight suture sleeve.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
 
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Brand Name
SENTUS PROMRI OTW QP S-85/49
Type of Device
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key14349682
MDR Text Key291348331
Report Number1028232-2022-02406
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479145606
UDI-Public04035479145606
Combination Product (y/n)N
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model Number406082
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/10/2022
Initial Date FDA Received05/10/2022
Supplement Dates Manufacturer Received05/31/2022
Supplement Dates FDA Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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