MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3708660

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that "the deepest contact path of deep brain stimulation (dbs) extension wire 37086-60 was not accessible".The extension was replaced to complete the procedure.The cause of the event was noted to be unknown.It was clarified that there were 4 contacts on the dbs extension wire.The deepest contact referred to the connection between the bottom contact of the lead and the lead.The path was not accessible during the intraoperative test, and there are no problems with the implant or the tunnel and the stimulator.The lead and ins were not damaged.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

Manufacturer Narrative

Analysis of the extension (serial no.(b)(4)) found that the connector on the distal end was twisted in molded rubber.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7554370
• MDR Text Key: 109621735
• Report Number: 2649622-2018-09025
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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 Expiration Date: 12/29/2021
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 08/13/2018; 08/08/2018
• Supplement Dates FDA Received: 08/07/2018; 08/14/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2017
• 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: 35 YR