MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor
|
Back to Search Results |
|
Model Number 37602 |
Device Problems
Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Battery Problem (2885)
|
Patient Problems
Shaking/Tremors (2515); Electric Shock (2554)
|
Event Date 06/12/2023 |
Event Type
Injury
|
Event Description
|
The manufacturer representative (rep) reported patient noticed return of symptoms, tremors, about 2 weeks ago.He had noted shocking sensation around the implantable neurostimulator (ins) and then the ins died.Patient checked and stim was off and eri had triggered at some point.Ins battery level is showing 2.9v today.Caller noted the patient is programmed to c1 3.4 60pw rate 150 and unable to take impedances.Previous showed c1 318ohms, c2 405ohms, c2 1100+ c3 1100+longevity showed 2+years estimate.Caller will discuss with surgeon and noted impedances after replacing ins today.Additional information received from the manufacturer¿s representative (rep) reported the date of replacement was june 26, 2023.The patient¿s impedance issues were: monopolar 1 249 ohms, 0 230 ohms and bipolar 0 1 144 ohms.Following replacement, the shocking sensations resolved.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|