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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 Malposition of Device (2616)
Patient Problems Tissue Damage (2104); Reaction (2414)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type implantable neurostimulator. Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot#: unknown, product type: lead. Product id: neu_ins_stimulator, serial/lot #: unknown. Product id: neu_ins_stimulator, serial/lot #: unknown. Product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Graziano, f. , gerardi, r. M. , lo bue, e. , basile, l. , brunasso, l. , somma, t. , maugeri, r. , nicoletti, g. , giacopino, d. Surgical back risk syndrome and spinal cord stimulation: better safe than sorry. World neurosurg. 2019. Doi: 10. 1016/j. Wneu. 2019. 09. 117. Summary: recurrent and chronic low back pain, caused by degenerative lumbar spondylosis, commonly affects elderly patients, even those with no previous low back surgery. These patients, like those affected by failed back surgery syndrome (fbss), may become unresponsive to medical conservative treatment and their quality of life could be easily compromised. Moreover, general comorbidities, obesity, and other typical conditions of the elderly may make surgery under general anesthesia riskier than the natural history of the disease. These patients could be considered affected by surgical back risk syndrome (sbrs). In this article, we report our preliminary observational prospective study on the role of spinal cord stimulation (scs) in 3 groups of patients: the fbss group, the sbrs group, and the ¿other¿ group. Selection criteria, treatment modality, and outcomes for each patient group are described and discussed. Moreover, a potentially useful diagnostic and therapeutic flowchart on the management options for lumbar back diseases is discussed. The fbss group included 25 patients, the sbrs group included 10 patients, and the other group included 3 patients. In 22/25 patients with fbss (88% of the total), the implantation of a definitive neurostimulator was successful. In almost all patients in both the sbrs and the other groups, the implantation of a definitive neurostimulator was successful. In our opinion, scs could be considered as a valid alternative treatment not only in selected patients affected by fbss but also in selected patients affected by sbrs, in whom back surgery under general anesthesia may be challenging and overcome the potential benefit of the surgery itself. Sbrs could be considered a new disease entity to be managed through scs. Reported events: a (b)(6)-year-old male patient (patient 14) with fbss implanted with an intellis implantable neurostimulator (ins) experienced a failure at their one month follow up. The patient had been operated on for decompression of the lumbar spine several years before admission at our department. After a brief period of symptom release, he reported severe low back pain associated with bilateral sciatalgia. A physical examination showed moderate to severe weakness of the lower limbs and intense pain in the lower back, easily evoked by hand pressure, and the lasègue maneuver was clearly positive. Magnetic resonance imaging showed multiple signs of degenerative spondylosis and disk degeneration along with anatomic alterations caused by previous lumbar surgery. Because of the patient¿s systemic morbidities, we chose to make him a candidate for scs surgery. During the procedure, excessive sedation decreased his compliance consistently and his ability to collaborate with surgeons. This situation implied suboptimal positioning of the electrodes. Although the patient had a small benefit from the procedure, when second surgery was proposed with the aim of improving the positioning of the electrodes, the patient refused and the temporary device was explanted. One patient experienced a surgical wound complication. The patient was affected by connective tissue diseases, which compromised successful scarring, and thus, removal of the system was mandatory. A (b)(6)-year-old male patient (patient 6) with sbrs implanted with a prime advanced implantable neurostimulator (ins) experienced a failure at their one month follow up. The neurostimulator was removed because of the anomalous fibro cicatricial reaction of the patient. No specific device information provided.
 
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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 Key9569400
MDR Text Key189609070
Report Number3007566237-2020-00047
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_ENS_STIMULATOR
Device Catalogue NumberNEU_ENS_STIMULATOR
Device Lot NumberUNKNOWN
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 Received12/16/2019
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: 01/09/2020 Patient Sequence Number: 1
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