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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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| Model Number 37601 |
| Device Problems
Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Patient Device Interaction Problem (4001)
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| Patient Problems
Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Pain (1994); Pocket Erosion (2013); Swelling (2091); Tingling (2171); Shaking/Tremors (2515); Electric Shock (2554)
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| Event Date 03/16/2020 |
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient had experienced shocking at the implantable neurostimulator (ins) and a replacement was performed, then the patient moved to another state and shocking was still experienced as occurring "with rigorous exercise" and pain was being experienced now at the ins site.No diagnostics/troubleshooting had yet been performed.It was stated a referral would be made from the neurologist to a neurosurgeon.It was unknown if surgical intervention would be planned and the issue was not resolved at the time of reporting.Additional information was received from a manufacturer representative (rep) on 2020-mar-19.It was clarified that the shocking and replacement was the same event that was previously reported.It is unknown if the issue has been resolved and if the neurosurgeon or the neurologist has seen the patient in their office and decided on treatment.The neurosurgeon has not indicated the patient is on the schedule.Additional information was received from a consumer via a manufacturer representative (rep) on 2020-mar-24.It was reported the shocking sensation was getting worse, reiterating that the shocking sensation has continued even after implantable neurostimulator (ins) and bilateral extension replacement in october.The patient feels shocking all the time with every step they take.The patient feels it at the header block and then feels it travel up into their brain.They could not confirm if the patient feels shocking unilaterally or bilaterally but thought it was on their left side.Previously the patient mentioned feeling shocking while doing rigorous activities but then it would go away and be fine.The rep realized during the call that the patient programmer (pp) is set to simple mode, so they can't adjust stimulation at all and can only turn it off or on.The patient does not want to turn their deep brain stimulation (dbs) off as they are not on any parkinson's disease medication because they are allergic to all the ones they have tried in the past.The patient asked if they should go to the emergency room (er) for the shocking.A short circuit on 8-9 pair was noted when the patient was seen in (b)(6) with a healthcare provider (hcp).They have not been seen by the hcp or rep since.They did not have exact impedance values but provided the programming below: 3.3v on left, 60 pw, 150 rate, 1- 2+ 3.5v on right, 60 pw, 150 rate, c+ 9- the rep spoke to another rep who covered the replacement and they could not remember for sure if lead-only impedances were checked at the time of replacement in (b)(6).They assumed that if the head incision was opened in order to replace the extensions, they likely would have checked lead-only impedances.However, if impedances were checked, they did not have any numerical values to provide.The patient has an appointment with a neurosurgeon on friday, (b)(6) 2020.Troubleshooting involved: suggested checking electrode and therapy impedances, palpating the system to attempt to recreate shocking, imaging of system and reprogramming to avoid using 8 and 9 contacts altogether and/or bipolar programming on right side along with considering giving patient advanced adjust mode on the pp, reviewing potential short circuit is worsening causing increased shocking sensation, potential that issue is with the lead as that has not been replaced and possibility of a fluid short, reviewing it is up to the patient to go to the er if they feel it is necessary but it is unlikely anything can be done immediately in terms of the system except turning it off and patient can do that at home if necessary, suggested if shocking seems to subside in certain positions, patient can try to spend majority of time in those positions in order to receive therapy and minimize shocking until further action can be taken.The rep called back as the patient wanted to know if the shocking would be harmful for them if they decided not to turn off stimulation, such as causing a stroke, or burn them.The shocking is bad and persistent in chest and also affecting the lead/extension.They also reported the ins does seem to be moving in pocket.It was indicated that with covid, it is difficult to meet with the patient in a low risk environment.The device off does not cause shocking.When the device is turned on, the patient feels tingling in their face.This has been going on for about 8 days.The rep called back again reporting the patient has pain in the pocket with palpation.There is slight swelling at the pocket site.The patient is on antibiotics for a urinary tract infection (uti).Battery check on (b)(6) was 2.97 volts and 2.96 volts today, thus, the drain on the battery is not fast like a short circuit.They reprogrammed the patient with 10+ and 9-, also 11+ and 10-, but the patient is still having rigidity in hands and legs with tremors.The patient has symptom relief with c and 9, but the patient has stimulation at pocket.They gave the patient the ability to adjust stimulation.The patient is at 2 volts now rather than 3.5 before.They were reminded that as the patient lowers stimulation level, symptoms may return, thus, it is up to the patient to determine a compromised setting for relief of more pocket sensation.Technical services also suggested trying c and 8-, however, it is not likely to help since c and 9 is already giving pocket stimulation.Possible revision if patient still can't tolerate pocket stimulation was discussed.The programmed parameters are: left 3.3 am 60pw 150hz 2520 ohms(therapy impedance) 1.3 ma right 3.5 volts 60pw 150hz 953 ohms(therapy impedance) 3.7 ma.
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Manufacturer Narrative
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Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2020, product type: extension.Product id 3708660, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2020, product type: extension.Product id 3389s-40, lot# va1twqh, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received stating the ins header was eroded through the chest pocket incision.The ins and extension were removed and a new extension was inserted with an abdominal ins.Once the new extensions were placed, the open circuits were gone.The cause of the shocking was not determined.Th patient did not report shocking after the ins was replaced.The cause of the stimulation at the pocket site was not identified.The devices will not be returned.
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Manufacturer Narrative
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D11.Section d information references the main component of the system and other applicable components are: product id 3708660 lot# serial# (b)(6) implanted: (b)(6) explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: (b)(6) explanted: product type extension 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.
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Event Description
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Additional information was received from a healthcare provider (hcp) via a manufacturer representative (rep) on (b)(4).It was reported the patient presented to the operating room complaining of intermittent shocking sensations around the implantable neurostimulator (ins) and up the neck.The clinician noted the ins was eroding through the skin.There are no known environmental/external/patient factors that may have led or contributed to the issue.Impedance measurements were taken and an open circuit was noted between contacts 8 and 9 on the right lead.X-rays were obtained to attempt to discover the reason for the shocking.No obvious fractures were noted from the x-rays.The patient was scheduled to have surgery on (b)(4) to revise the pocket and troubleshoot connections.
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Search Alerts/Recalls
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