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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Anxiety (2328); Discomfort (2330); Depression (2361)
Event Date 10/03/2017
Event Type  Injury  
Manufacturer Narrative
Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in continuation of medical devices: product id neu_ins_stimulator, product type implantable neurostimulator. Product id neu_ins_stimulator, product type implantable neurostimulator. Product id neu_ins_stimulator, product type implantable neurostimulator. Information references the main component of the system. Other relevant device(s) are: product id: neu_ins_stimulator; product id: neu_ins_stimulator; product id: neu_ins_stimulator. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Eghtesadi, m. , leroux, e. , fournier-gosselin, m. P. , lesperance, p. , marchand, l. , pim, h. , adelina, a. , beaudet, l. , boudreau, g. P. Neurostimulation for refractory cervicogenic headache: a three-year retrospective study. Neuromodulation. 2018. 21(3): 302-309. Doi: 10. 1111/ner. 12730 summary: occipital nerve stimulation (ons) has been used for the treatment of neuropathic pain conditions and could be a therapeutic approach for refractory cervicogenic headache (ceh). Aim: the aim of this study is to assess the efficacy and safety of unilateral ons in patients suffering from refractory ceh. We conducted a retrospective chart review on patients implanted from 2011 to 2013 at chum. The primary outcome was a 50% reduction in headache days per month. Secondary outcomes included change in euroqol group visual analog scale rating of health-related quality of life (eq vas), six item headache impact test (hit-6) score, hospital anxiety and depression scale (hads) score, work status, and medication overuse. Sixteen patients fulfilled the inclusion criteria; they had suffered from daily moderate to severe ceh for a median of 15 years. At one year follow-up, 11 patients were responders (69%). There was a statistically significant improvement in the eq vas score (median change: 40 point increase, p50. 0013) and hit-6 score (median change: 17. 5 point decrease, p50. 0005). Clinically significant anxiety and depression scores both resolved amongst 60% of patients. At three years, six patients were responders (37. 5%). Out of the 11 responders at one-year post implantation, five had remained heada che responders (r¿r) and one additional patient became a responder (nr¿r). There was a statistically significant improvement in the eq vas score (median change: 15 point increase, p50. 019) and hit-6 score (median change: 7. 5 point decrease, p50. 0017) compared with baseline. Clinically significant anxiety and depression scores both, respectively, resolved among 22. 5% and 33. 9% of patients. Five out of seven disabled patients were back to work. Ons may be a safe and effective treatment modality for patients suffering from a refractory ceh. Further study may be warranted. Reported events: one patient experienced an infection at the occipital incision site; the patient was explanted, treated with antibiotics and is awaiting reimplantation as they had had significant symptom relief with ons. One patient was reoperated due to discomfort at the connector anchoring site because of thin skin. One patient was reoperated due to discomfort related to neurostimulator migration to the abdominal wall excess skin, following important weight loss after bariatric surgery. One patient was explanted after two years due to lack of benefit from ons. No specific device information was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameNEU_INS_STIMULATOR
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 Key7718272
MDR Text Key114973224
Report Number3007566237-2018-02207
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Device Lot NumberUNKNOWN
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 Received12/20/2018
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: 07/25/2018 Patient Sequence Number: 1
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