MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problem Electric Shock (2554)

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported they experienced shocking in the chest.The patient states the shocking gets intense after every recharging session of their implantable neurostimulator (ins).Lately, it takes the patient 30-45 minutes to recharge the ins and it used to take only 15 minutes.They recharge every day and has all 8 bars shaded when recharging.They start recharging at the same level each time and recharged to 100% each time.The patient said they had fallen at least 6 times within the last month, prior to the report, and fell the day of the report.It was recommended that the patient follow up with their healthcare provider (hcp) about their shocking, falls, and longer recharging sessions.The ins is indicated for dystonia.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5799558
• MDR Text Key: 49744330
• Report Number: 3004209178-2016-14343
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: 06/23/2016
• Supplement Dates FDA Received: 09/23/2017
• Date Device Manufactured: 08/26/2010
• 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: 55 YR