MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG STRATOS LV; CRT-P

Model Number 338200

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2016

Event Type  Injury  

Event Description

Rep was advised after the fact that device had been sawed into pieces by surgeon having difficulty removing medtronic lead 4195-88 from lv header.Rep does not have further information regarding events including date of occurrence.Device return has been requested.

Manufacturer Narrative

On (b)(6) 2016: an op note provided by the hospital states the associated rv lead was capped during this procedure, due to oversensing.This device had reached eri.Added the explant and event dates.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: STRATOS LV
• Type of Device: CRT-P
• 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: 5963087
• MDR Text Key: 55129405
• Report Number: 1028232-2016-03314
• Device Sequence Number: 1
• Product Code: NKE
• 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: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 338200
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2009
• 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: 84 YR