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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 Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Scar Tissue (2060); Discomfort (2330); Increased Sensitivity (4538); Insufficient Information (4580)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2021. Product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 27-jan-2025, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 27-jan-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

On 2021-apr-12, information was received from a patient via manufacturer (rep) representative who was implanted with an implantable neurostimulator (ins) for radiculopathy and spinal pain. It was reported that the patient¿is extremely small <(>&<)> her leads had some difficulty advancing, but md got into what she felt was a good position. The area subcutaneously where her implanted leads are anchored <(>&<)> the ins is located have seemed to remain sore beyond what would be considered within normal healing period. ¿patient was anorexic according to her <(>&<)> had increased her weight from (b)(6) to (b)(6) as encouraged by md to be able to be a candidate for the trial/implant. ¿patient therapy was not initiated till (b)(6) 2021, due to slower than normal wound sensitivity. ¿patient was programmed <(>&<)> groups set for her to evaluate, yet she feels that her results are not like trial <(>&<)> md has asked if she wants it removed. Patient is not wanting to remove, but sensitivity around s implant wounds remains an issue <(>&<)> she does not yet feel results consistent with trial. We are continuing to evaluate groups <(>&<)> titration of groups. The issue has not been resolved at this time, and it's unknown if surgical intervention will occur. On 2021-04-14, additional information was received from a rep. The rep reported that the cause of the difficulty advancing the lead wasn't determined. The rep noted that perhaps there was scar tissue from the trial. The rep reported that they would see the patient and reprogram on (b)(6) 2021. The rep reported that the symptoms had perhaps a little had been resolved. The patient's body habitus was very petite. On 2021-04-14, additional information was received from the manufacturer representative (rep) reporting that the patient and medical doctor decided to explant the system. The patient had been back and forth on efficacy and they had tried multiple programs for relief, but were unsuccessful. The patients discomfort with the anchor area and battery site had promoted her and their doctor to remove it. Although in preop they stated that today they woke up and wanted to keep it. The medical doctor stated that the patient had parkinsons which may tend to impact their decision making.

 
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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 Key11822358
MDR Text Key262899836
Report Number3004209178-2021-07701
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
Report Date 05/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/17/2021
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: 05/13/2021 Patient Sequence Number: 1
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