MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG STRATOS LV-T; CRT-P

Model Number 338202

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 12/01/2015

Event Type  malfunction  

Event Description

Ous mdr - at follow-up in (b)(6), the device was close to eri.However, the follow-up in (b)(6), suddenly showed 4 months to eri again.Nothing was technically changed in this time period.Programmed output: a: 2.4 v @ 0.4 ms, rv: 2.4 v @ 0.4 ms, lv: 3.0 v @ 1.5 ms no automatic adjustment.Battery voltage: 2.72 v at 3.17 kohm.Device was explanted on (b)(6) 2016 and still showed 4 months until eri during the follow-up before op.At a repeated interrogation in the office, suddenly eri with today's date is displayed.Implantation took place on (b)(6) 2011 and not on 12 sep 2013, as stored in the device.

Manufacturer Narrative

First the manufacturing process of this device was reviewed.The production documents did not show any anomalies.All manufacturing steps had been carried out correctly.The pacemaker's capability to provide therapy was tested.The antibradycardic output signal matched the programmed values, and the signal sensing of the device was normal.The pacemaker showed specification-conforming behavior in regard to its device functions.The pacemaker underwent a status interrogation, during which the device status eri was displayed.The eri status was triggered at the day of the explantation on (b)(6) 2016.The pacemaker was implanted for about 56 months.The charge drawn from the battery was checked.The battery depletion proved to be as expected.The eri state on (b)(6) 2016 resulted from storage of the pacemaker in a cold environment after the explantation.In all pacemakers with lithium iodide batteries, the impedance of the battery is low at the beginning of the operating time and only increases over the operating time of the implant.Therefore, the display of the remaining operating time at the beginning of the pacemaker service lifetime is calculated solely based on the drawn charge.With increasing battery impedance, the battery impedance is gradually taken into account for the determination of the remaining operating time.The objective is to switch to the "in this state of discharge" precise impedance measurement with increasing age.Due to the successive switch from the calculation based on the remaining operating time to a calculation based on the battery impedance measurement, temporary vacillations of the remaining operating time display are possible.The observed phenomenon is thus not a material defect or manufacturing error but the result of determinations of the remaining operating times as they are adjusted to the respective discharge states.Independent of the adjustment of the remaining operating time until the eri time, a remaining charge quantity for about 12 months operating time after eri detection is reserved in the pacemaker to ensure patient safety.In summary, the device state was as expected.In particular, the device state eri at the day of the explantation was activated because of storage of the pacemaker in a cold environment.There was no material defect or device defect.

• Brand Name: STRATOS LV-T
• Type of Device: CRT-P
• 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: 5432010
• MDR Text Key: 38064176
• Report Number: 1028232-2016-00321
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 338202
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2011
• 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