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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 Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  Malfunction  
Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 17-may-2023, udi#: (b)(4); product id: 97 7a260, serial/lot #:(b)(4), ubd: 17-may-2023, 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) for non-malignant pain. It was reported that while the patient was charging last night, they used "60% of their battery" and "normally 45 minute charge takes them down to like 30%". The patient said that since they were charging earlier, they thought "well, it will use up 40% of the battery". The patient thought what was weird was they charged for 45 mins and only used "30% of their battery" and patient said that "it's never done that". The patient also said that their back has been hurting more than usual. The patient said that they were concerned that a lead has come undone. The patient said that this is the first time this has happened. The patient said that one time, they accidentally turned off their stimulation and did not know they did; patient said they turned the power off. The patient said that when they accidentally did this in the past, within 24 hours they could hardly walk. The patient said that yesterday was just a really bad day and when they went to charge "it only used half the power to charge". The patient said that normally if they are at 30% "it takes 70% charge to 100".   the patient said that the pain started probably yesterday morning. The patient said that in the past, "it usually take 24 hours" like the time they "turned it off" but this time "it was like 12 hours. " the patient was redirected to their healthcare provider to further address the issue.

 
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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 Key12361011
MDR Text Key267918842
Report Number3004209178-2021-12850
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 CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2020
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 Received09/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/29/2019
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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