MAUDE Adverse Event Report: MPRI ACTIVA

Model Number 3708660

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the stage two procedure, after tunneling the extension cable, it was noticed that the extension was bent.The extension was left in the patient disconnected.It will be attached to a lead at a future date.It is unknown if impedances are normal because it is not fully connected at this time.There were no factors that may have led or contributed to the issue, no diagnostics/troubleshooting performed, and no actions taken.It is unknown if the issue was resolved.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11862395
• MDR Text Key: 251936200
• Report Number: 2649622-2021-10189
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000236830
• UDI-Public: 00763000236830
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 05/21/2021
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR