MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97714 |
Device Problem
Battery Problem (2885)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/20/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: date inaccurate, only the year is valid.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 non-malignant pain.It was reported that several months ago it started to take the patient three to four hours to charge the ins, even with full coupling bars.Starting two to three months ago, their ins would not hold a charge and it wouldn't last 24 hours.They had to lay on their back to get the ins to charge (as that was what they found to be the best recharging position).There were times when charging would shut off because the recharger would say the antenna was getting too hot.The patient had not changed any programs, and only changed their intensity slightly up and down.A replacement recharger antenna was requested.The patient was advised to follow up with their healthcare provider regarding their issues.No symptoms or further complications reported.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 37791 serial# unknown 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.
|
|
Event Description
|
Additional information was received.It was reported the circumstances that led to the ins not holding a charge was it just started not holding a charge overtime, it wasn't sudden.The paddle was replaced and their manufacturer representative added another channel.The issue was not really resolved.
|
|
Search Alerts/Recalls
|
|
|