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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); Battery Problem (2885); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead, product id: 977a260, serial#: (b)(4), product type: lead, product id: 97745, serial#: unknown, product type: programmer, patient. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 05-nov-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 24-mar-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) for spinal pain. The reason for call was pt stated that the ins has not worked for a long time - asked unknown event date. Pt stated the leads moved - pt stated they did an xray and found the leads had moved. Pt has not used or charged the ins in a long time. Pt is seeing another hcp about about replacing the current ins. Pt stated she is not sure if it will be another medtronic ins or a different company.   pt said their stim hadn't been used for several months because their leads moved and was no longer working. Pt wanted assistance with getting into mri mode (pt mentioned that they used mri mode before). Patient services tried to assist pt with recharging the ins however, pt saw the battery empty, recharge the controller screen. Pss reviewed to allow the controller to fully recharge (green light on controller was flashing) and then to try and recharge the ins, pt will call back if they need further assistance. Pt said the date and time on their controller were incorrect; pt said they would update them once the ins was recharged.
 
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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 Key12516777
MDR Text Key272908979
Report Number3004209178-2021-14284
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2021
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 Received09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/21/2020
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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