MAUDE Adverse Event Report: MPRI CAPSURE VDD 2; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number	5038-58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: addr01 ipg, implanted (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported an infection occurred.The implantable pulse generator (ipg) system was explanted.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.No anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSURE VDD 2
• Common Device Name: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8237394
• Report Number: 2649622-2019-00641
• Device Sequence Number: 1745811
• Product Code: DXY
• UDI-Device Identifier: 00643169325678
• UDI-Public: 00643169325678
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/08/2020
• Device Model Number: 5038-58
• Device Catalogue Number: 5038-58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/05/2019
• 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: D017538 VALVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR