MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97712 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Burn(s) (1757); Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 377775, lot#: v003918, implanted: (b)(6) 2006, product type: lead.Product id: 377760, lot#: v004734, implanted: (b)(6) 2006, product type: lead.Other relevant device(s) are: product id: 377775, serial/lot #: (b)(4), ubd: 22-feb-2010, udi#: (b)(4); product id: 377760, serial/lot #: (b)(4), ubd: 14-mar-2010, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that pt guesses in the year 2015 one of the implant leads came off and burned their rear.Pts hcp that did the implant was dr.(b)(6) and the managing hcp was dr.(b)(6).
|
|
Event Description
|
Additional information was received.It was reported the patient did not know the cause, they just felt burning and looked red about the size of a half dollar.It was noted their healthcare provider went in and stated one of the leads had come loose.The healthcare provider had left it and did not reconnect and the patient stated it was no longer a hot wire.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 377775 lot# v003918 serial# implanted: (b)(6) 2006.Explanted:.Product type lead product id 377760 lot# v004734 serial# implanted: (b)(6) 2006.Explanted:.Product type lead.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.
|
|
Search Alerts/Recalls
|
|
|