MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ECURO DR-T PROMRI; PACEMAKER

Model Number 377367

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

Ous mdr - after an implantation period of about 20 months, a battery depletion was reported.The pacemaker was replaced and the two leads were reconnected to the new device.The pacemaker was returned to biotronik.No adverse patient side effects have been reported.

Manufacturer Narrative

Upon receipt, the device was interrogated revealing the battery status eri.During the interrogation a warning message was triggered regarding the battery condition.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be flawless and in amplitude and frequency as programmed.There was no indication of a device malfunction.At a next step the memory content of the device was inspected.During the device interrogation it was observed that the battery status eri was triggered on (b)(6) 2014 as a result of a depleted battery.However, the memory content documented that the current consumption was normal.Therefore, the pacemaker was opened and subjected to further analysis.The visual inspection of the inner assembly showed no anomalies but the battery was found to be depleted.The battery was disconnected from the electronic module.Further thorough investigation of the electronic module did not show any anomalies.In particular the current consumption proved to be normal and expected.At a next step the battery was sent to the manufacturer for analysis.Analysis results of the battery: the manufacturing process for the battery was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.Subsequently the battery was subjected to a visual and an electrical inspection, including x-ray as well as microcalorimetry analysis and confirmed the battery depletion.However, the destructive analysis did not reveal any abnormality which might have led to the an early depletion of the battery.In summary, despite the dedicated analysis, the root cause of the early battery depletion could not be determined.The therapy functionality of the pacemaker was not compromised while implanted and in service.

• Brand Name: ECURO DR-T PROMRI
• 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: 4363971
• MDR Text Key: 5290452
• Report Number: 1028232-2014-006176
• 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: 12/11/2014

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: 377367
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2012
• 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