• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD Back to Search Results
Model Number 355149
Device Problems Break (1069); Failure to Capture (1081)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2022
Event Type  malfunction  
Event Description
This lead was explanted due to non capture.Lead tip broke off during explant.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
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.
 
Manufacturer Narrative
Upon receipt, the lead under complaint was found severely fragmented.An extraction aid was found in the lead body.The proximal fragment (including the connector) and the distal fragment (including the lead tip) were not returned for analysis.Due to the severely fragmented state of the lead the definite root cause of the reported loss of capture could not be determined.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COROX OTW-S 85-BP
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 Key15632914
MDR Text Key302010342
Report Number1028232-2022-05372
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/12/2022
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 Date09/30/2017
Device Model Number355149
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 10/12/2022
Initial Date FDA Received10/19/2022
Supplement Dates Manufacturer Received10/21/2022
12/16/2022
Supplement Dates FDA Received10/25/2022
12/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2015
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;
Patient Age67 YR
Patient SexMale
-
-