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

Model Number 37612

Device Problems Battery Problem (2885); Charging Problem (2892); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 03/29/2018

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 patient via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that the patient was recharging every 2 days for 1.5 hours as the device would drop to 75%.The patient confirmed that they could achieve all coupling bars when recharging and the device does charge to 100% when they complete it.The patient's settings were noted as the following: l stn, monopolar contact 2, 2.5/90/180 r stn, monopolar contact 2, 4/90/180 the therapy impedances were noted as greater than 1700 ohms, bilaterally.The rechargeable implantable neurostimulator (ins) was rep laced just before easter.There was no known impact or consequence to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

Entry corrected to product problem.Event date approximate.Corrected to malfunction as there is no indication original explant was due to device issue and/or was unexpected intervention.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturing representative (rep) and confirmed with the healthcare provider (hcp) indicated the patient had been incorrectly educated about how often to recharge.They had been educated so hopefully the issue was resolved.

• 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: 7490535
• MDR Text Key: 107470743
• Report Number: 3007566237-2018-01355
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 05/10/2018
• 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
• Patient Outcome(s): Required Intervention