MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 3058 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Rash (2033); Discomfort (2330); Tissue Breakdown (2681)
|
Event Date 04/18/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that they had discomfort immediately after implant. about 4 months after their second implanted device, (b)(6) 2019, they developed a rash.This chronic rash and sores recur often on their legs and trunk.The patient turned off their device 2 years after placement in (b)(6) 2020, after they developed shingles.The patient continues to have issues with post-hepatic neuralgia.In (b)(6) 2021, they turned off their device and has never restarted it.They didn't think the device helped their bladder control issues.They want it removed.They think it may be the cause of chronic rash.On 2023-sep-28 additional information was received from a healthcare professional (hcp).The hcp reported that it is unknown if the device/therapy/procedure was casual or contributory to the shingles and rash as the patient had not related this concern to them, however the patient does have an appointment next month for a check.The patient is wanting the device removed because they feel that the device is causing the shingles.
|
|
Search Alerts/Recalls
|
|
|