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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problem Insufficient Information (3190)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead. Product id: 977c165, serial/lot #: (b)(4), ubd: 05-apr-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacture representative reported that the patient experienced epidural bleeding after they were implanted. It was noted that the lead was explanted. The healthcare provider stated that this event had nothing to do with the product from medtronic. From their view, this epidural bleeding came from the surgical part and not from the material. No further complications were reported/anticipated.
 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9474621
MDR Text Key185586617
Report Number3007566237-2019-02549
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
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/16/2019 Patient Sequence Number: 1
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