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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Ambulation Difficulties (2544)
Event Date 12/14/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead, other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 21-nov-2024, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient was implanted. The patient went to the recovery room and was initially fine and moving everything. About 30 min later she claims she could not move anything and couldn't feel anything. The patient was taken back to or and removed the device. Did not find any crazy amount of bleeding. Patient fine - kicking and happy - after the removal. The patient will also be having an mri.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11020703
MDR Text Key222002150
Report Number2182207-2020-01504
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received12/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/18/2020
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: 12/16/2020 Patient Sequence Number: 1
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