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

Model Number 356248

Device Problems Failure to Interrogate (1332); Premature End-of-Life Indicator (1480)

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

Event Date 08/08/2014

Event Type  malfunction  

Event Description

Ous mdr - after an estimated implantation period of about 72 months, it was reported that the pacemaker could not be interrogated and eos was suspected.Furthermore it was reported that during a follow up on (b)(6) 2013, the device indicated a calculated remaining battery life-time of 4 years and 9 months.The device was explanted and returned to biotronik.The date of implant was not provided.

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 re-investigated.All production steps had been performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt the pacemaker could not be interrogated, confirming the clinical observation.Furthermore no therapy functionality was present.Therefore, the pacemaker was opened to examine the inner assembly and to check the functionality of the electronic module.A visual inspection showed no anomalies.However, the battery was found to be depleted.At a next step the electronic module was attached to an external power supply.In the course of analysis the electrical parameters, particularly the current consumption of the electronic module, were found to be normal and as expected.The ability of the device to deliver therapies was verified.The anti-bradycardia therapy functions proved to be within specification.The memory content of the device was not restorable due to the battery depletion.Hence, the programmed parameters since the last follow-up were not determinable.The battery was sent to the manufacturer for a further detailed analysis.Analysis of the battery the manufacturing records were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated to this battery.During the electrical measurement, the battery depletion was confirmed.However, a visual inspection and x-ray imaging of the battery did not reveal any signs of damage.The destructive analysis of the battery yielded no anomalies.The amount of charge taken from the battery was verified.The battery condition was found to be anticipated for a depleted battery.There was no indication of a workmanship or a material problem.Summary: the battery of the pacemaker was found to be depleted.Despite a thorough and time consuming analysis no conclusion can be drawn regarding the root cause of the clinical observation, in particular the analysis of the electronic module as well as the battery did not show any anomalies.

• Brand Name: TALOS 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: 4088613
• MDR Text Key: 4827467
• Report Number: 1028232-2014-003236
• Device Sequence Number: 1
• Product Code: DXY
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 356248
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2008
• 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