MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problems
Failure to Deliver Energy (1211); Use of Device Problem (1670); Delayed Charge Time (2586)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2012 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id: 37751, serial# (b)(6), product type recharger.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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Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was caller reported in probably the last 6 months, quite a few times their ins had shut off by itself.The caller stated that once or twice was due to the ins battery getting too low, but the other times just seemed to have shut off on its own.Patient services (pss) redirected patient to a healthcare provider (hcp).The patient also reported since first getting the ins, they have constantly had to pull at the harness to get the antenna to line up/stay over ins to get an efficient full charge.The caller stated within about the last 3 years, they noticed their ins was taking longer to charge, and that they would get all 8 boxes filled in the majority of time, but they had to keep moving the harness/antenna to keep in proper position to get the boxes filled.Caller stated the recharger antenna was in excellent shape, and mentioned they had a recharger antenna replaced once before a couple years ago.The caller inquired about whether there was a new harness or something available.Pss reviewed the wireless recharger and elective replacement program.As caller had moved and no longer had a provider, pss reviewed they would reach out to local reps with notification, and reviewed that once they get an hcp, to inform them of transition request to wr to be able to transition and hcp could contact reps to help order.No symptoms reported.
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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 received from the consumer reported they didn¿t know what led to the device turning off and the charging issues they experienced as they had surgery that the device was turned off for and it turned back on after the procedure.According to the consumer they could typically go up to three days when fully charged before they had to charge again, but they normally didn¿t go that long.The consumer was now charging more often; every other day with their activity level being less than before due to other physician conditions.
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