MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-S 75-BP; LV LEAD

Model Number 355148

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 12/22/2014

Event Type  Injury  

Event Description

Initially the right ventricular and coronary sinus leads were inserted and secured; a stress relieving loop was constructed.Coronary sinus venogram revealed an edge dissection at the superior portion.There were no suitable branches for lead placement.No effusion was seen on echo and the patient was hemodynamically stable throughout entire procedure.This lead was not implanted and no other lv lead was used.This is all of the available information at this time.Should additional information become available, this event will be updated.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

• Brand Name: COROX OTW-S 75-BP
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 4484094
• MDR Text Key: 5350017
• Report Number: 1028232-2015-000236
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 355148
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR