MAUDE Adverse Event Report: BIOTRONIK BIOTRONIK ELUNA 8 DR-T PROMRI; IMPLANTABLE PACEMAKER

Model Number ELUNIA 8 DR-T PROMRI

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/24/2017

Event Type  Injury  

Event Description

Biotronik cardiac pacemaker implanted (b)(6) 2016 model eluna 8 dr-t promri 68430083.This was a change out of pulse generator.Since change he notes a positional low dose electrical current sensation when supine or on left side.No muscle twitching.Cardiologist and pacemaker rep say nothing wrong with device.Patient and i believe device having electrical discharge into chest wall that is positional.

• Brand Name: BIOTRONIK ELUNA 8 DR-T PROMRI
• Type of Device: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 6356267
• MDR Text Key: 68401118
• Report Number: MW5068095
• Device Sequence Number: 1
• Product Code: NKE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2017

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 Model Number: ELUNIA 8 DR-T PROMRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IMPLANTED:; IMPLANTED:; SERTROX S 53 LEAD; SERTROX S 60 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 97