MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Impaired Healing (2378); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/12/2015 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: 37601, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 3387s-40, lot#: va0kxfg, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot#: va0apd4, implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 23-apr-2017, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: (b)(4), ubd: 15-may-2016, udi#: (b)(4).Refer to manufacturer report #3004209178-2020-14252 for related system.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer who reported they were being scheduled to have the implantable neurostimulator (ins) and leads removed tomorrow.The consumer reported in (b)(6) they started feeling pain near the left side leads; there was no redness or anything, but then a dark spot appeared.The neurologist checked the consumer in (b)(6) and found an infection and the wound wasn¿t healing.The consumer unsure what caused the infection but in 2015 the left hand lead wire was ¿sticking out and something was oozing so the healthcare provider (hcp) just ¿snipped the wire off.¿.
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Manufacturer Narrative
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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 the consumer reporting they cleaned the area and removed all wires and battery and put on iv antibiotics for 6 weeks or more.The physician handled the explanted devices and never sent them.
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Manufacturer Narrative
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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.
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Event Description
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Additional information received from the consumer reported due to the infection the implantable neurostimulator (ins) and both leads were removed in august of last year.The patient currently had 2 new leads implanted (the second lead was implanted on (b)(6) 2021), and their healthcare provider (hcp) intended on implanting 2 non-rechargeable batteries on (b)(6) with each battery attached to one lead.The hcp decided to implant 2 non-rechargeable devices because the rechargeable device couldn't connect to a single lead.
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