MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT

Model Number	407685
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	01/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the full lead was returned.Analysis was performed and no anomalies were found.The proximal conductor of the lead became extrinsically fractured due to melting.The outer insulation of the lead was extrinsically breached due to melting.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was experiencing occasional complete heart block.An x-ray verified both the right atrial (ra) and right ventricular (rv) leads had dislodged.Both leads were explanted and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX NOVUS
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7417047
• Report Number: 2649622-2018-04628
• Device Sequence Number: 16384498
• Product Code: DTB
• UDI-Device Identifier: 00613994329400
• UDI-Public: 00613994329400
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2017
• Device Model Number: 407685
• Device Catalogue Number: 407685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR