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

Model Number	5592-45
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Undesired Nerve Stimulation (1980)
Date of Event	10/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5092-52 lead, implanted: (b)(6) 2016; 5867-3m adaptor implanted: (b)(6) 2016; 5867-3m adaptor implanted: (b)(6) 2016.
Event or Problem Description
It was reported that within one week post-implant, the patient went to the emergency room due to diaphragmatic and nerve stimulation.Device interrogation revealed no atrial capture along with increased output.X-ray showed that the lead was pulled back and dislodged.The atrial lead was programmed off until being repositioned the next day.The lead remains in use.No 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: CAPSURE SP NOVUS
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6157939
• Report Number: 2649622-2016-13915
• Device Sequence Number: 13709293
• Product Code: DTB
• UDI-Device Identifier: 00643169590724
• UDI-Public: 00643169590724
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• 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): 10/23/2016

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: 01/21/2018
• Device Model Number: 5592-45
• Device Catalogue Number: 5592-45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2016
• Supplement Date Received by Manufacturer: 10/23/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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: (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR