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

Model Number 368346

Device Problem Programming Issue (3014)

Patient Problem Muscle Stimulation (1412)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient commented on feeling thumping during the night while hospitalized post device upgrade with the lv lead implant.This was resolved prior to discharge, but during a routine one-week post-implant clinic device check, patient again commented on feeling thumping in the chest when lying down.Lv lead output decreased from 5.0 v to 3.0v.Aside from the thumping, no other adverse patient effects were reported.Should additional information become available, this event will be updated.

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-L 85-BP
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 5051501
• MDR Text Key: 24872429
• Report Number: 1028232-2015-03165
• 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
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 368346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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): Other
• Patient Age: 79 YR