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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient felt their ins had been discharging more abruptly and more quickly than usual.The patient charged their ins at night 4 days prior to 75%, and the next morning the therapy was suddenly discontinued.On interrogation the battery was at 0%.The patient stated it happened once more since.When they charge they typically get 8 coupling bars.They usually charge for 1.5 hours and the ins is usually at 25% to 50% at the end of the next day.The recharging stats were analyzed, and it was found at the recharge session the night before the patient lost therapy the average coupling was not very good, and the recharge session did not last very long.There was multiple 4 minute sessions in which the recharger was not connected due to poor coupling.It was also stated that there were instances where the battery voltage was showing 0v when it was known there was a charge on the ins.The manufacturing representative attempted three charging sessions with their recharger and all was fine.There were no abnormalities seen on the patient's ins data.The patient's recharger was replaced.It was reported that there were no additional actions planned outside of replacing the recharger, and it was unknown if the issue was resolved at this time.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9721578
• MDR Text Key: 191169507
• Report Number: 3007566237-2020-00259
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• 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