MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PHILOS II DR; PACEMAKER

Model Number 341826

Device Problem Failure to Interrogate (1332)

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

Event Date 11/12/2014

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of about 56 months, it was reported that the pacemaker could no longer be interrogated.The device was exchanged and returned to biotronik for analysis.No deterioration of the patient's state of health was reported.

Manufacturer Narrative

The pacemaker was returned for analysis.The production process for this device was checked.The production documents did not show any irregularities that could be linked to the complaint.All production steps were correctly executed.After receipt, the implant was subjected to a visual inspection.The housing showed slight swelling, suggesting a discharged battery.The electrical test for the implant confirmed the clinical observation.The pacemaker could not be interrogated and the antibradycardia therapy function was not available.The device was then opened and the electronic module was visually analyzed.The interior construction showed no irregularities.The battery was found in a discharged state.During the next step, the battery was separated from the electronic module and the electronic module was subjected to electrical testing.With the connection of an external power supply, the pacemaker functionality was fully functional.The power consumption was normal and no irregularities were observed.There were no indications of the electronic module malfunctioning.The battery was returned to the manufacturer and was examined in detail.The extensive battery test showed that the battery was fully discharged.Nevertheless, the analysis showed a typical discharge.There was no indication of a battery defect.Summary: the clinical observation was confirmed.The analysis showed that the root cause was the discharged battery.In spite of the detailed analysis, the reason for the discharged battery could not be determined.Neither the battery nor the electronic module exhibited signs of a defect.

• Brand Name: PHILOS II DR
• Type of Device: PACEMAKER
• 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: 4337199
• MDR Text Key: 21775061
• Report Number: 1028232-2014-006105
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 341826
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 12/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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