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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was caller stated that their manufacturer representative (rep) told them to call for a replacement recharger.Caller stated for the last month their implant has been acting up.Caller stated that sometimes the implant doesn't want to charge completely and sometimes it takes an hour and a half to charge.Caller added that the monitor says that stimulation can't be read at this time.Caller mentioned that this is the second time this has happened, and they are going to see rep on monday to look at the monitor again.Caller repeated that rep thinks the recharger needs to be replaced.Agent attempted to ask clarifying information, but caller was vague with their response.Caller did not have the equipment at the time of the call.Caller will be calling back with their external equipment.Patient called back to provide serial numbers to external equipment.During the call, agent walked patient through resetting the controller with the ac power cord.Patient confirmed no damage to the controller port or pins, recharger cord and pins.Agent walked patient through a recharging session and the patient confirmed recharging excellent.During troubleshooting the patient reported "settings not available, cannot provide your desired intensity settings (59)".Patient mentioned the reason they're concerned about their equipment is because they cannot feel stimulation and their implant has not depleted at the rate it normally does.Agent reviewed information with the patient.The issue was not resolved.Agent re-directed patient back to their hcp and mdt rep.Caller reported they are meeting with a rep on monday.
 
Manufacturer Narrative
Date is approximate.Year is confirmed valid.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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Brand Name
INTELLIS
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key18826579
MDR Text Key337761702
Report Number3004209178-2024-06181
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00763000315467
UDI-Public00763000315467
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2024
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/25/2024
Initial Date FDA Received03/04/2024
Date Device Manufactured07/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
Patient SexMale
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