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

Model Number 407156

Device Problem No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2022

Event Type  malfunction  

Event Description

After an implantation period of approx.One month, it was observed at an in-office follow-up that there is a lead error because the v pacing configuration change to unipolar.The lead was replaced with a new ventricular lead and connected to the ipg.Pacing was not possible with this ipg so it was explanted and a new ipg was connected to the leads.

Manufacturer Narrative

The pacemaker and the ventricular lead were returned for analysis.Prior to the analysis of the devices, the quality documents accompanying the manufacturing process were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was interrogated properly and the pacemakers memory content was analyzed indicating no anomalies.The battery was found to be fully charged.Statistical and trend data were not available for analysis, as the statistics were restarted on (b)(6) 2022.The header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the is-1 standard specifications.Also the spring elements of the pacemaker did not show any deviations.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.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.No intermittent or permanent loss of output was present.Upon receipt, the lead under complaint was received for analysis.The analysis showed that the insulation of the lead was found squeezed and damaged 20.5 cm distal to the is-1 connector pin, which is assumed to be the root cause of the clinical observations.The insulation damage most likely resulted from tightening the suture sleeve to the lead body.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: ENTICOS 4 D
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15491642
• MDR Text Key: 300723456
• Report Number: 1028232-2022-04959
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 407156
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• 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