MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Electric Shock (2554); Unspecified Nervous System Problem (4426); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 37751, serial#: (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding an implantable neurostimulator (ins).The patient reported that their ins "relocated itself and moved down" in (b)(6) 2019.The patient added that the ins has not moved since then, noting that it's "parked." the patient mentioned that the manufacturer¿s representative (rep) came to see them a couple of times and told the patient that it's "not a problem at all" as long as they are able to get all 8 coupling bars filled in when recharging the ins.However, the patient started to notice a shocking sensation when they charged their ins.The patient explained that the sensation normally began as "a little pulsation," but the sensation got worse the longer they charged the ins.The patient stated that they brought their recharger to a healthcare provider (hcp) appointment and the hcp told them that "a little electrical pulse should be normal." the patient countered and stated, "the entire thing is shocking my left side and makes my teeth chatter." the patient mentioned that they thought the shocking sensation may have been caused from having the desktop charger (dtc) plugged into a surge protector.The patient stated that they called the rep and they advised the patient to plug the dtc into a grounded outlet.The patient stated that they did as advised and recharging was "okay for a while," but then they started to experience the shocking sensation again.Despite the shocking sensation, the patient stated that their ins is charged to "at least half." the patient recently had the recharger antenna replaced, but they started to have coupling issues again (the coupling bars would fluctuate when the patient wasn't moving).It was noted the patient used adhesive discs to help with coupling.The patient stated that they need a new set screw (the one that holds the corner cap in place over the recharger antenna) because it got stripped from loosening and retightening it when they replaced the recharger antenna.The patient learned a newer recharger was available and they should request one.In the meantime, a replacement recharger was going to be sent but it was also suggested to have the hcp check the ins.The patient mentioned that they have been fighting migraines since 2017 and have been getting botox injections to help with the migraines because the "spasms are so bad." the patient added that the migraines are from dystonia and stated that their ins was implanted to treat dystonia, but no allegations were made regarding therapy.The manufacturer¿s representative (rep) later reported on may 20, 2016 the patient went from one primary cell device to another.On (b)(6) 2018 the patient was implanted with a rechargeable device.The rep noted the primary cell devices were much larger in size and volume compared to the rechargeable device meaning they had a larger surgical pocket.Due to this it was ¿very common to go from a dual channel primary cell neurostimulator to a smaller rechargeable for there to be some neurostimulator movement, and it would by typical based on the patient¿s anatomy, surgical position, and patient movement.¿ the rep stated with noting this there would be an issue if it impacted the patient¿s ability to couple the device to the recharger, but it didn't seem to be the case with this patient.The rep noted many patient¿s were being told about the new wireless recharger and it¿s ease of use by the physician.The rep asked to have the hcp notify them of any true issues patients experienced to investigate the issue further.Unrelated coupling and damaged desktop charger event captured in pe (b)(4).

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

It was reported that they received a recharger replacement due to a coupling issue, but the coupling issue persisted.The patient stated that they can get all 8 coupling bars to fill in, but it can be difficult and they have to reposition the recharger antenna frequently to get better coupling.The patient was redirected to their healthcare provider to further address how the ins battery moved and the coupling issue associated with that.The patient indicated that the shocking sensation was painful and that it hurt them.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 11302991
• MDR Text Key: 244076227
• Report Number: 3004209178-2021-02266
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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: 05/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/11/2021
• Date Device Manufactured: 07/12/2018
• 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
• Treatment: SEE H10
• Patient Age: 49 YR
• Patient Sex: Female