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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 High impedance (1291); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Seroma (2069); Discomfort (2330)
Event Date 07/29/2021
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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. Manufacturer representative (rep)¿ reports she was in the or when the paddle lead was implanted. Caller reports post implant, the lead connection check and impedances were all fine. Caller reports patient is seen today to turn stimulation on. Caller reports when she attempted to turn stimulation on, patient feels a strong right rib, under his breast area shocking sensation. Caller reports she could not continue with the electrode impedance. Caller reports the electrodes in red: 4,5,6, and 7. Suggest re-running the impedance, caller reports once it was on electrode 4, patient could not tolerate, testing had to stop. Redirect caller to patient's hcp. Suggest x-ray of the lead placement. It was reported that manufacturer representative (rep) had¿difficulty getting an impedance check without causing discomfort difficulty getting an impedance check without causing discomfort. The patient had a paddle lead scs implant on (b)(6) 2021. Rep arranged to meet with the patient a week later ((b)(6) 2021) to turn his stimulator on and educate him on recharging his device. Rep interrogated the battery and attempted to run an impedance check. However, had to immediately abort because it was causing too much discomfort for the patient. Rep attempted impedance checks two additional times, each time using a different electrode as the reference electrode but had to abort each attempt. Rep then assessed the connectivity of the leads in the lead select screen. This showed slots 4,5,6,7 as having a red x and the remaining slots as green check marks. ¿ tech services advised to run an impedance check using one of the red x electrodes. Rep attempted to run an impedance test with the #4 electrode as reference electrode but again, had to immediately abort due to worsening discomfort to the patient. Rep did not turn his stimulator on at that time, and informed¿ implanting physician. Hcp was able to see the patient in his office later that afternoon and scheduled further imaging and work up at the hospital. On (b)(6) 2021, rep ran a successful (no discomfort to the patient) impedance check. It showed electrodes 2,3,4, and 7 as orange and 5 as a red x. Rep was able to program around these electrodes and the patient received good stimulation coverage. He will be following up with hcp again in one week and we will be present at that appointment to further assess.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12263390
MDR Text Key264759818
Report Number3004209178-2021-11775
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/03/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/02/2021 Patient Sequence Number: 1
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