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

Model Number	5038S-52
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the medial portion of the lead was returned, analyzed and no anomalies were found.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 experienced pain, local swelling, and redness around the device pocket after the device had been migrating to the surface with slight erosion.It was noted that the device area had become more irritated with activity and with the use of a seat belt.Approximately a week later, the patient was given antibiotics as a precaution.The patient's symptoms continued to persist with no relief from antibiotics, so an official diagnosis of device infection was made about a month later, followed by the implantable pulse generator (ipg) system explant.The system was later replaced.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.No further patient complications have been reported as a result of this event.

• 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: 7411624
• Report Number: 2649622-2018-02991
• Device Sequence Number: 962899
• Product Code: DXY
• UDI-Device Identifier: 00681490122832
• UDI-Public: 00681490122832
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/05/2009
• Device Model Number: 5038S-52
• Device Catalogue Number: 5038S-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) IPG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 96