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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 Migration or Expulsion of Device (1395); Charging Problem (2892); Data Problem (3196)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Paresthesia (4421); Insufficient Information (4580)
Event Date 10/29/2020
Event Type  Malfunction  
Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 09-jul-2024, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 09-jul-2024, udi#: (b)(4). 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). It was reported that the patient mentioned the lead wire moved "a little bit", causing difficulty with getting the therapy to target the desired location in the patient's body. Patient services (pss) asked, and the patient reported these issues started about a week after implant. The patient stated that around this time, they had been recharging the ins 2x/week. The patient reported that 2-3 months ago, they met with the manufacturer representative (rep) who did reprogramming on the ins so that the patient did not feel paresthesia from the therapy. The patient reported that they got the expected therapeutic relief for 1-2 months after the reprogramming session and did not need to recharge the ins for 2 months. The patient reported during this time they were "out of pain". The patient reported approx. 5-10 days ago, they experienced a return of pain. The patient reported that their "back is killing them", they are "miserable", and cannot even stand up. The patient stated that they had to take 3 pain pills this morning to address the pain. The patient reported that 3 days ago, they recharged the ins after seeing the ins battery low message, but the issues have not resolved. The patient confirmed group a was active, the ins was on, and programs 1-4 were available to adjust. The patient noted that program 1 suddenly went from 3. 7ma to 0. 0ma on the phone. Pss walked the patient through adjusting program 1 back to 3. 7ma, but is reaching out to the field for further assistance regarding programming. The issue was not resolved. Additional information was received from the manufacturer representative (rep). It was reported that the patient was seen on (b)(6) 2021 in the physicians office. The patient told the rep that he had been doing good for 5-6 weeks, so well in fact, that his battery died and he did not realize it until the pain returned. When he came in to meet with the rep he had his battery fully charged. The rep simply had to turn his system back on and reset his dtm settings. All his impedances are wnl¿s. The patient was happy after the visit.

 
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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 Key12333687
MDR Text Key266974267
Report Number3004209178-2021-12529
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
Report Date 08/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2021
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 Received07/20/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/31/2020
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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