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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_ENS_STIMULATOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Sepsis (2067); Test Result (2695)
Event Date 09/28/2017
Event Type  Injury  
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 977d260, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: screening device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturing representative (rep) regarding a patient with an external neurostimulator (ens). It was reported that the patient complained of pain. The patient was trailed with a lead on (b)(6) 2017. The trial leads were removed after successful trail on (b)(6) 2017. Upon time of removal, no concern for any device related issues. The patient received benefit from the therapy. The rep was contacted by the patient's wife on 10-04-2017 who stated that the patient was experiencing left shoulder pain and upper back pain. The rep was asked if this was related to the patient's trial. The rep informed the family to contact the patient's managing physician to discuss his symptoms and any questions he might have regarding his trail. The patient's family was agreeable to this plan. The complaint was after the patient's trial lead was removed. No further patient symptoms or complications were reported in this event. Additional information was received from the health care professional (hcp) via the rep. It was reported that the patient developed multiple symptoms several days after the completion of this trial, including joint pain, pleural effusion, epidural abscess, sepsis, and had significantly increased hemoglobin a-1 c. Patient was seen by neurosurgeon and cardiothoracic surgeon for these issues. The patient is discharged home per health care professional (hcp). No further patient symptoms or complications were reported in this event.
 
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Brand NameEXTERNAL 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 Key7010159
MDR Text Key91352796
Report Number3007566237-2017-04729
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
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,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNEU_ENS_STIMULATOR
Device Catalogue NumberNEU_ENS_STIMULATOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
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: 11/08/2017 Patient Sequence Number: 1
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