MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTICOS 4 DR; PACEMAKER

Model Number 407155

Device Problems Loss of Threshold (1633); Impedance Problem (2950)

Patient Problem Exit Block (2628)

Event Date 12/03/2018

Event Type  Injury  

Event Description

Ous mdr - after implantation, it was reported that, due to an exit block in the rv, no stimulation threshold and no impedance in the ventricle could be determined during follow-up.

Manufacturer Narrative

After the device was received, the pacemaker status was interrogated and the memory was analyzed.The pacemaker was visually inspected and the connection system was examined.The screw and the spring element of the lead connections were in working order.Leads inserted for test purposes were easily accessed, low ohm, and reliably contacted.The bore dimension was also within the dimensions set forth in the standard.The therapy capabilities of the pacemaker were checked.The anti-bradycardia output signal reflected the values programmed and the device signal sensing was in working order.With respect to device function, the pacemaker was within specifications.In addition, a long-term pacing test was performed.No problems were found with the pacing function.The device was not found to be compromised in its ability to deliver therapy.In summary, the device was fully functional during analysis, as was within specifications with respect to the connection system and electronics.There was no material or manufacturing defect present.

• Brand Name: ENTICOS 4 DR
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8297227
• MDR Text Key: 134742280
• Report Number: 1028232-2019-00319
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 407155
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1