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

Model Number 3389-28

Device Problems Shipping Damage or Problem (1570); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Device was never implanted, and therefore never part of a system.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a user facility via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.The lead was twisted when removed from package by the physician.A new lead was used and the event resolved.There was no troubleshooting performed and no external factors noted.No patient harm was reported.

Manufacturer Narrative

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

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.The lead was twisted when removed from package by the physician.A new lead was used and the event resolved.There was no troubleshooting performed and no external factors noted.No patient harm was reported.On 12/21/2018, (for, hcp, rep): no new information.(corrected previous event description regarding initial reporter).

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.

Manufacturer Narrative

The returned lead was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.(b)(4).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: 8172207
• MDR Text Key: 130625448
• Report Number: 2649622-2018-20792
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 3389-28
• Device Catalogue Number: 3389-28
• Device Lot Number: VA1TG22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• 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