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

Model Number	4076110
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Undesired Nerve Stimulation (1980)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 37603 dbs ipg implanted: (b)(6) 2016; 3708660 neuro extension implanted: (b)(6) 2016; 3387s-40 lead implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced nerve and diaphragmatic stimulation.The right atrial (ra) lead had dislodged and was found in the superior vena cava (svc).The rv lead had also dislodged and was found in the right atrium.Both leads were repositioned and remain in use.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: 7418223
• Report Number: 2649622-2018-05104
• Device Sequence Number: 11171825
• Product Code: DTB
• UDI-Device Identifier: 00643169550865
• UDI-Public: 00643169550865
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 12/05/2018
• Device Model Number: 4076110
• Device Catalogue Number: 4076110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• 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: 63 YR