MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 401661

Device Problems High impedance (1291); High Capture Threshold (3266)

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

Event Date 11/13/2015

Event Type  malfunction  

Event Description

After an implantation time of about 3 months, the following was reported:on (b)(6) /2015, an this crt-d was implanted from the right without an atrial lead.The lv lead dislodged.On (b)(6) 2015, the systems was explanted on the right and implanted on the left.On (b)(6) 2015, lv and rv pacing impedances higher than 3000 ohm and shock impedance values higher than 150 ohm were detected during the follow-up.On (b)(6) 2015, unremarkable measurement values were reported during the planned revision.The connection was also described as unremarkable.The physician decided to connect a new device.The icd was returned to biotronik for analysis.Biotronik has no information whether the leads implanted with the system were left in place or also explanted.No deterioration of the patientstate of health was reported.

Manufacturer Narrative

The returned icd first underwent a status interrogation.The device status was bos, six charge processes had been registered.The memory content of the icd was checked.During the analysis of the trend data, the clinical observation could be confirmed.On (b)(6) 2015, a left- and right-ventricular pacing impedance of >3 kohm and a shock impedance of >150 ohm was documented.However, the results of the manual impedance measurement on (b)(6) showed normal and expected values.The measurement values shown in the trend data are the result of several performed automatic impedance measurements within the previous 24 hours.In the case that one or several automatic measurements return values outside of the measurement range, the measurement value of the day is displayed accordingly as such.It can therefore be assumed that an automatic impedance measurement was performed while the icd was in the water bath, as described, which provided values outside of the measurement range for all three channels and then led to the clinical observation.The impedance measurement functions of the icd were checked.The impedance measurement functions behaved properly during testing.There were no indications of a malfunction.The icd's ability to provide therapy was tested.The antibradycardic output signal was normal and matched the programmed values.A fibrillation signal was supplied, and the device reacted according to specification with a defibrillation shock.The specified energy level was reached, and the charge time proved to be unremarkable.In summary, the clinical observation could be confirmed.On (b)(6) 2015, the device data showed a documented pacing impedance of >3 kohm in the left and right ventricle, as well as a shock impedance of >150 ohm, which was very likely due to the described interim storage of the icd in the water bath.A thorough check of the therapy and impedance measurement functions showed proper device behavior.There were no indications of a device malfunction.

• Brand Name: ITREVIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• 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: 5330889
• MDR Text Key: 34512415
• Report Number: 1028232-2015-04579
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401661
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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