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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICE CREEK MFG SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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RICE CREEK MFG SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Event Date 11/28/2019
Event Type  Injury  
Manufacturer Narrative
Literature citation: lee cy, wu t, chang cw, lim sn, cheng my, lee st. Electrical cortical stimulation for treatment of intractable epilepsy originating from eloquent cortex: surgical accuracy and clinical efficacy. Acta neurochirurgica. 2019. Doi: 10. 1007/s00701-019-04137-3 literature abstract: electrical cortical stimulation is shown effective in treating patients with drug-resistant epilepsy. The authors demonstrated how detailed procedures of pre- and intra-operative planning of cortical stimulation implantation may influence the results of seizure reduction rate. Pre-surgical planning enhanced the accuracy of electrode placement and led to a favorable seizure reduction rate. Our report confirms that electrical cortical stimulation with detailed implantation procedures is safe and effective for patients with drug-resistant epilepsy originating from eloquent cortex. Date of event: please note this date is based off of the article¿s online publication date as the specific event date was not provided in the published literature. It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Device used for off label indication. The indication the device was used for was electrical cortical stimulation. Concomitant medical products: product id: 3587a, lot #: unknown, product type: lead. Product id: 3587a, serial/lot #: unknown, ubd: asku, udi#: asku. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported a (b)(6)-year-old male (patient 3) experienced recurrent scalp inflammation resulting from an allergic reaction to the device cable. The patient had their device removed four years after implant as a result. No further complications were reported or anticipated.
 
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Brand NameSYNERGY
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
Manufacturer (Section G)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9826449
MDR Text Key185916369
Report Number6000030-2020-00132
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeTW
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 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number7427
Device Catalogue Number7427
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 Received02/11/2020
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: 03/12/2020 Patient Sequence Number: 1
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