• 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 STRATOS LV-T CRT-P

  • 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 STRATOS LV-T CRT-P Back to Search Results
Model Number 338202
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/22/2016
Event Type  malfunction  
Event Description
Ous mdr - the patient had radiotherapy and this device was interrogated after that event and was found to be at eri. The follow-up before the radiotherapy estimated the battery had 6 months. There were no adverse patient side effects reported. The device was explanted but has not been returned for analysis.
 
Manufacturer Narrative
The pacemaker was received for analysis. Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were reinvestigated. All production steps had been performed accordingly. Particularly the final acceptance test proved the device functions to be as specified. The pacemaker was implanted for 101 months. Upon receipt, the clinical observation was confirmed, the device interrogation revealed the battery status eri. Based on the inspection of the pacemakers memory content the eri status was triggered on (b)(6) 2016 most likely as a result of the reported radiotherapy. However, the amount of charge taken from the battery was verified. The battery condition was found to be as expected. The ability of the device to deliver therapies was verified. The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed. There was no indication of a device malfunction. In conclusion, the battery status eri resulted most likely from the reported radiotherapy. During analysis the pacemaker was fully functional.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRATOS LV-T
Type of DeviceCRT-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 Key6180942
MDR Text Key62678198
Report Number1028232-2016-05004
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number338202
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
-
-