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Model Number 8637-40 |
Device Problems
Inappropriate or Unexpected Reset (2959); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 8709, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2020, product type catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 18-mar-2008, udi#: (b)(4).Analysis of the pump revealed an anomaly of having been improperly programmed in manufacturing.Regarding analysis, a session report and logs were retrieved after numerous attempts with a programmer.The pump was received in safe mode.The logs showed the last known state was eri (elective replacement indicator) and that a reset had occurred.The returned catheter was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing.Analysis of the catheter identified coring/tearing/cuts in the cup of the sutureless connector that met leak criteria in the laboratory.Visual inspection also identified a break in the catheter.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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The pump and catheter were returned to the manufacturer from an unknown source regarding a patient who was receiving an unspecified drug of unspecified concentration at an unspecified dose rate via an implantable pump for intractable spasticity.No further information was provided.
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Manufacturer Narrative
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H3: the previously reported analysis result for pump ngv481709h was determined to be incorrect.Updated analysis results determined the pump reached end of service (eos) based on time progression, as expected.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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Search Alerts/Recalls
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