MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ELUNA 8 DR-T PROMRI; PACEMAKER

Model Number 394969

Device Problem Over-Sensing (1438)

Patient Problems Cardiac Arrest (1762); Death (1802); Coma (2417); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2016

Event Type  malfunction  

Event Description

Ous mdr - after an implantation period of approx.1 year, it was reported that the patient suffered from cardio-respiratory arrest in the afternoon of (b)(6) 2016.One electrical external shock was delivered.Arterial fibrilation was triggered after the external shock.Further more oversensing and impedance values out of range were reportedly recorded in october.At the moment biotronik has no further information with regard to a revision procedure.

Manufacturer Narrative

On (b)(6) 2017 - it was reported that the patient died on (b)(6) 2016.After the vf episodes, the patient remained in a coma.She was reported to be in a critical neurological state and never woke up again.She died in the intensive care.The pacemaker was explanted and returned to biotronik for analysis.

Manufacturer Narrative

Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.The battery status was found to be larger than 90 percent.The data from the last follow ups on (b)(6) 2016, documented high values of the bipolar ra pacing impedance of 2100 ohms.No other peculiarities were noted.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 is1 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.Additionally the impedance measurement functions of the device were tested.The tests documented a regular device behavior.

• Brand Name: ELUNA 8 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: 6213854
• MDR Text Key: 63560582
• Report Number: 1028232-2016-05114
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

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: 394969
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2017; 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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): Death; Hospitalization