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

Model Number 365463

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Collapse (2416)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

It was reported that the (b)(6) patient was on vacation in (b)(6) when he collapsed and was hospitalized.In the hospital the pacemaker was reportedly found in status "end of service" after an implantation period of approx.89 months, although in (b)(6) 2018 the predicted battery life has been reportedly more than one year.

Manufacturer Narrative

The pacemaker under complaint was returned for analysis.Upon initial interrogation a warning message was displayed on the programmer screen regarding the battery condition.The battery status was eri, which was triggered on (b)(6) 2018.In a next step the memory content of the device was inspected.The inspection revealed that the battery voltage decreased faster than expected, confirming the clinical observation.However the current consumption was normal.The data further documented that the battery voltage temporarily dropped to a particular low value below the eri threshold on (b)(6) 2018.Under this condition the ability of the device to deliver anti-bradycardia therapy may be inhibited, which can be considered to be the root cause of the clinical observation on (b)(6) 2018.In the following weeks the battery voltage recovered higher values which enabled the pacemaker to resume the therapy functionality.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.Therefore the device was opened and subjected to further investigation.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage confirmed a depleted battery.The battery was disconnected from the electronic module.The electronic module was attached to an external power supply to inspect its functionality.A thorough investigation did not show any abnormality.In particular, the current consumption was directly measured and proved to be normal and expected.The battery was sent to the manufacturer for further analysis.The manufacturing records of the battery 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.The battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis.The visual inspection of the battery did not reveal any external signs of damage.The measurement of the battery voltage confirmed a depleted battery and the microcalorimetry analysis showed an elevated heat dissipation.Subsequently, the battery was opened for destructive analysis.During the inspection of the inner assembly of the battery an internal insulation damage was identified, which led to an elevated internal self-depletion within the battery and therefore contributed to the clinical observation.In conclusion, the device was implanted for 90 months.The analysis revealed that an internal insulation damage within the battery contributed to a battery depletion faster than expected.Particularly, a temporary voltage drop below the eri threshold was documented on (b)(6) 2018.Based on the information available for analysis, it cannot be excluded that the therapy functionality of the device was temporarily unavailable on (b)(6) 2018, which presumably led to the clinical observation.

• Brand Name: ENTOVIS DR-T
• 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: 7562018
• MDR Text Key: 109885439
• Report Number: 1028232-2018-01867
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365463
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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