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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Electro-Static Discharge (2149); Device Displays Incorrect Message (2591)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Prezelj, n., trost, m., georgiev, d., flisar, d.Lightning may pose a danger to patients receiving deep brain stimulation: case report.J neurosci.2018.Doi: 10.3171/2017.12.Jns172258.Please note that this date is based off the date that the article was accepted for publication as the event was not yet available online when the manufacturer became aware of the event.If information is provided in the future, a supplemental report will be issued.[prezelj_lit.Pdf].

Event Description

Summary: deep brain stimulation (dbs) is an established treatment option for advanced stages of parkinson¿s disease and other movement disorders.It is known that dbs is susceptible to strong electromagnetic fields (emfs) that can be generated by various electrical devices at work, home, and in medical environments.Emfs can interfere with the proper functioning of implantable pulse generators (ipgs).Very strong emfs can generate induction currents in implanted electrodes and even damage the brain.Manufacturers of dbs devices have issued a list of warnings on how to avoid this danger.Strong emfs can result from natural forces as well.The authors present the case of a (b)(6) woman who was being treated with a rechargeable dbs system for neck dystonia when her apartment was struck by lightning.Domestic electronic devices that were operating during the event were burned and destroyed.The woman¿s ipg switched off but remained undamaged, and she suffered no neurological consequences.Reported events: a (b)(6) woman with bilateral globus pallidus internus (gpi) deep brain stimulation (dbs) for dystonia experienced ¿very good¿ clinical response; approximately five years after implant the electrical installation of her apartment was struck by lightning during a thunderstorm, causing her implantable neurostimulator (ins) to switch off and electrical devices that were in use at the time, such as a television and air conditioner, to be burned and destroyed.No dbs recharging accessories were charging during the event, so they were undamaged.The patient reportedly noticed something was wrong only an hour after the storm subsided when dystonic neck tremor reappeared.When she checked the function of her ipg, the power on reset (por) warning appeared on her patient programmer¿s display.Upon visiting their health care provider (hcp) the ins was confirmed to be turned off, but all stimulation parameters remained unchanged, the battery remained 50% charged (as expected), and the system overall was found to be undamaged.The patient¿s dystonic tremor resolved almost immediately after turning the stimulator back on and the patient suffered no other neurological consequences.It was not possible to ascertain any additional specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

Additional review indicates this information was already reported in manufacturer¿s report #3007566237-2017-00722.Any additional information regarding the event will be submitted as a supplemental submission to that report.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): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7550370
• MDR Text Key: 109575620
• Report Number: 3007566237-2018-01604
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR