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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 Problems Pain (1994); Insufficient Information (4580)
Event Date 07/06/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider, clinical study, manufacturer representative) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient experienced pocket pain and it disturbed her. The doctor examined and saw the scar was calm on (b)(6) 2020. There was possibly the upper part of the device was "close as stick of the scar" but no sign of infection. The pocket pain was due to implant procedure. Neurotol patch was prescribed on (b)(6) 2020. It was observed that when she was standing the device puts itself horizontal in the belly. The doctor examined her on (b)(6) 2020 and the pain was less than before so decided to let it and wait and see. As she had pain on her left side and no operation will be done, decided to introduce and test a second lead and connect it on this device which is "reposition" on this intervention. Additional information was received reporting the second lead was connected when the ins was repositioned on (b)(6) 2021. The outcome was ongoing as of (b)(6) 2021.
 
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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 Key12301251
MDR Text Key265820705
Report Number3004209178-2021-12156
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2020
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: 08/10/2021 Patient Sequence Number: 1
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