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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Break (1069); Electromagnetic Interference (1194); Delayed Charge Time (2586); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Swelling/ Edema (4577)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 13-mar-2022, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 13-mar-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The healthcare professional (hcp) reported through a manufacturer representative (rep) that they ¿suspected leads may have been cut during a recent spinal surgery. ¿ impedance testing performed on (b)(6) 2021 found ¿all impedances were normal. ¿ a rep involved with the event noted ¿the date on the implantable neurostimulator (ins) was out (2011), so he suspected electrocautery interference. ¿ ins interrogation results from (b)(6) 2021 noted the ¿device battery had depleted to the point of therapy unavailability in the time since the last session¿ and that the ins ¿time was more than 90 minutes off from the programmer¿ used during the interrogation. The patient reported significant pain behind the ins/left buttock; an x-ray was requested. The patient reported that as of (b)(6) 2021 that they still had surgical pain from her spinal surgery and that it was consequently too difficult to tell if her spinal cord stimulation therapy was helping or not. It was noted the patient was ¿only getting additional/new pain when recharging. The ¿site also swelled and was painful during/after recharge. ¿ the patient was advised to turn their charging speed down from 4 to 1 in an attempt to not heat up as much and hopefully reduce issues. The patient tried charging on 1, but noted it took too long and increased it again. The patient was advised on (b)(6) 2021 to turn her stimulation off so she didn't have to keep recharging and causing subsequent ins discomfort and swelling. The patient was reviewed by their implanting physician on (b)(6) 2021 and the hcp ¿suspected possible hematoma behind ipg from blood tracking down leads. ¿ the patient was to be left to ¿settle for two weeks¿ and was advised to keep the stimulator off in order to avoid recharging until the issue settled. It was noted the rep was to ¿review her face-to-face for reprogramming and continuation of therapy if all is good by then. ¿ there were no surgical interventions performed and it was unknown whether any were planned as of (b)(6) 2021. There were no further complications reported or anticipated.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11387050
MDR Text Key244001053
Report Number3004209178-2021-03333
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P840001
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 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
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 Received04/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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