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

Model Number 371992

Device Problems Impedance Problem (2950); No Pacing (3268)

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

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This device was explanted because there was no pacing from the device.The pocket was close on device then reopened because no impedance field would populate when connected to device.There were no other adverse patient events reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.The battery was found to be fully charged.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.There was no intermittent or permanent loss of output.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: ENTOVIS DR-T PROMRI
• 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: 5320319
• MDR Text Key: 34171114
• Report Number: 1028232-2015-04569
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371992
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• 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
• Patient Age: 70 YR