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

Model Number	5076-85
Medical Device Problem Codes	Failure to Sense (1559); Device Dislodged or Dislocated (2923); Appropriate Device Problem Term/Code Not Available (3191); High Capture Threshold (3266)
Health Effect - Clinical Code	Muscle Stimulation (1412)
Date of Event	12/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-45 lead, implanted: (b)(6) 2009.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced diaphragmatic stimulation from their right ventricular (rv) lead.It was also noted the lead exhibited high thresholds and no sensing was observed in both bipolar and unipolar configuration.A chest x-ray revealed that the lead had dislodged.The lead was reprogrammed off.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6320291
• Report Number: 2649622-2017-01494
• Device Sequence Number: 532868
• Product Code: DTB
• UDI-Device Identifier: 00643169550797
• UDI-Public: 00643169550797
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/13/2018
• Device Model Number: 5076-85
• Device Catalogue Number: 5076-85
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2016
• Supplement Date Received by Manufacturer: 12/18/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADDR01 IPG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR