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

Model Number 37603

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscular Rigidity (1968); Pain (1994); Burning Sensation (2146); Neck Stiffness (2434); Sleep Dysfunction (2517); Electric Shock (2554); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that since (b)(6) 2021, the patient (pt) had been having trouble with being in pain.The caller said pt had been in the hospital and they felt last year that the battery was "swelling just a little bit".The caller said a month later, they thought it was caused by the pt's wisdom teeth because the pt had some trouble with them.Caller said in (b)(6) 2021, the pt had problems again and the neurosurgeon told the pt they needed to see pain management and also directed pt to see their movement disorder doctor.Pt got a second opinion somewhere around (b)(6) 2021 from another neurosurgeon, in which the healthcare provider (hcp) told the pt they could just take the whole dbs system out.Caller said pt doesn't sleep, they felt like device was shocking them.Pt said it felt like their chest was burning where the implants were located.When the device is turned off, the issues get better, but pt can't stand to have the dbs off because then the dystonia got bad.Pt had dystonia mainly on their left side and caller said they didn't know why they have the device for the right side because pt took botox for their left side.Caller said for the past 7-10, days pt had increased dystonia.Caller said right battery (that controls the left side) was at 2.88v a week ago and had dropped to 2.84v.Caller said that pt had seemed to do fine until their implant battery voltage dropped to a certain level.Caller said every time the patient had the implant battery changed, the patent would get worse right before, caller said pt would be in pain.Caller said they attributed this to the battery voltage getting lower and the pt's body responding to this.Caller told hcp this and hcp told caller that it was because the patient had been under a lot of stress.Caller said that they knew pt had been under a lot of stress but that shouldn't be caused by stress.Caller said hcp had just been blowing off the issues and thought pt was faking them.Caller had asked hcp to check device programming and impedances.Pt doesn't have an appointment until (b)(6) 2022.Pt has appointment with doctor's assistant on (b)(6) 2022.Patient had an issue of having to unlink/relink devices.After troubleshooting, it was found that only the left implant was linked.Pss was able to successfully link both implants.It turned out the right implant was off.The caller turned therapy back on because they didn't want therapy to be off.

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

Additional information was received.The patient rep repeated medical information from the previous call that included the patient feeling shocking and burning.The patient rep stated the movement disorder doctor discussed the placement of the batteries last tuesday and told the patient rep that "it does not look right".The patient rep reported that one battery seems taut and up, while the other is almost in her armpit, stating the movement disorder doctor believes the wires may be pulling, and the battery may be out of the pocket due to the patient growing in size and increase in tissue around the implant site (the patient rep stated the patient had gone up 3-4 bra sizes).The patient rep mentioned they are visiting the neurosurgeon today, and "waiting on the new percept because she's never had luck with the activas.".

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 13804227
• MDR Text Key: 290093584
• Report Number: 3004209178-2022-03432
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Date Device Manufactured: 09/10/2019
• 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): Hospitalization
• Patient Age: 14 YR
• Patient Sex: Female