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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); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 977a290, lot# serial# (b)(4), implanted: (b)(6) 2020, product type lead. Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 14-dec-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 via manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that the patient went into the clinic for reprogramming because they were only feeling stimulation in their right hand. Patient (pt) states this occurred in august of this year after they were rolling on a medicine ball doing exercises then felt a ¿pop. ¿ after this incident they no longer felt stimulation in their right shoulder and only felt it in their right arm. A lead check was done and confirmed that the left lead did migrate down only one electrode. The patient was reprogrammed so that the pt was able to feel stimulation in their right shoulder. There is no need for surgical intervention at this time, for patient is now feeling stimulation in correct location after reprogramming. This issue has been resolved.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12685087
MDR Text Key278140127
Report Number3004209178-2021-15791
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2020
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 Received10/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/19/2019
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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