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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Sleep Dysfunction (2517); Electric Shock (2554); Insufficient Information (4580)
Event Date 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
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 unknown indications for use.Patient reported the reason for the call was that he woke up this morning and it felt like someone was sticking a needle right in where the implant was right at the bottom where the wires was and whenever he moved to the right or left it felt like he was getting a shock.Patient said his implant was currently off, patient said he always turned off implant at night because sometimes he will turn over in his sleep and it would wake him up so if he was in a lot of pain he would have the device on during the day.Patient said he may have to go to the er to check the implant to see if everything was hooked up right with his device, patient said he had an xray last night and they said everything was okay.Patient reported no falls/trauma.The circumstances that led to the reported issue were asked but unknown.Troubleshooting was unable to be performed as patient made his hcp aware of issue and hcp told patient to call mdt for information, patient said he had been afraid that the implant battery could be leaking or the lead wire could be poking through.The patient was redirected to their healthcare provider to further address the issue.
 
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
Additional information was received from the patient.The patient reported that they had resolved the issue by not recharging the battery, has slowly stopped for the time being.The patient was supposed to meet with a manufacturer's representative (rep) for follow up.
 
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Brand Name
IMPLANTABLE NEUROSTIMULATOR
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
MDR Report Key11709200
MDR Text Key247356870
Report Number2182207-2021-00680
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received04/22/2021
Supplement Dates Manufacturer Received05/07/2021
Supplement Dates FDA Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
Patient Weight116
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