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

Model Number 341822

Device Problems Failure to Interrogate (1332); Pacing Problem (1439)

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

Event Date 11/23/2016

Event Type  malfunction  

Event Description

Ous mdr - shortly after the implantation, when the pocket was closed, no pacing was recorded, but impedance measurements were in range, and the device could not be interrogated.It was decided to replace the device.The pacemaker was not returned to biotronik.No adverse patient side effects have been reported.

Manufacturer Narrative

The pacemaker was received for analysis.In agreement with the clinical observation, the pacemaker was neither interrogatable nor was any output signal present.Efforts to reset the pacemaker using a technical programming tool were partly successful.A warning message was triggered subsequently indicating a severely invalid memory content.Further attempts to reset the device were unsuccessful.Therefore the pacemaker was opened to perform a hardware reset.After the reset a normal interrogation was properly feasible.The memory content of the device was not restorable due to the hardware reset.Therefore, the origin of the invalid memory content is unknown.The pacemaker was subsequently subjected to an electrical analysis.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.In addition, a long-term storage test at different temperature environments were performed.No deviations were noted during the analysis, in particular the memory content remained valid.The quality documents accompanying the manufacturing process for this pacemaker were re-investigated.All production steps had been performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.The memory content during the production at biotronik was valid.In conclusion, the clinical observation was confirmed.The analysis revealed an invalid memory content leading to the clinical observation.After a hardware reset the device proved to be fully functional.Despite exhaustive attempts the failure condition was not reproducible.The root cause for the invalid memory content was therefore not determinable, however, it cannot be excluded that strong electromagnetic fields during the implantation might have contributed to the clinical event.

• Brand Name: PHILOS II SLR
• Type of Device: PACEMAKER
• 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: 6213860
• MDR Text Key: 63559446
• Report Number: 1028232-2016-05066
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

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: 341822
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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