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

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.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, 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 Key: 9826449
• MDR Text Key: 185916369
• Report Number: 6000030-2020-00132
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR