MAUDE Adverse Event Report: MPRI ACTIVA

Model Number	3387S-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that both of the patient's leads were exposed but the patient did not report any symptoms.The hair covered the exposure so the patient did not know it was visible.The factors that may have led to this issue was the rep was told the patient's scalp is very thin.The leads and extensions were explanted and replaced.The issue was resolved.
Additional Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot#: va24afn, implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 08-oct-2022, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 08-oct-2024, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 08-oct-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13334146
• Report Number: 2649622-2022-01617
• Device Sequence Number: 11983359
• Product Code: PJS
• UDI-Device Identifier: 00643169752290
• UDI-Public: 00643169752290
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA24AFN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/24/2022
• Date Device Manufactured: 12/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female