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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION 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); Inflammation (1932); Malaise (2359); Skin Inflammation (2443)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 977d260, serial# (b)(4), product type: screening device. Product id 977d260, serial# (b)(4), product type: screening device. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received about a patient implanted with an implantable neurostimulator (ins). It was reported that earlier this week the patient had surgery to remove a spine abscess. The patient had a trial scs on (b)(6) 2017. They came in for their lead pull on (b)(6) 2017. At that time the patient wanted to extend her trial a couple of days so that she could be certain. The patient's leads were redressed. It was noted that the patient does have psoriasis and there were areas of inflammation but none around the two leads. The patient came back for the lead pull on (b)(6) 2017 but the rep was not in attendance. The rep then called to follow up with the patient and they reported feeling ill with flu like symptoms. It was noted that members of her household had recently been ill. The rep tried to follow-up several times with the patient without success and just recently discovered that she had surgery to remove the abscess.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). The rep reported that the serial number on the leads was unknown. The cause of the spinal abscess is that it is a presumed as a result of an infection following an scs trial.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6347900
MDR Text Key67923882
Report Number3007566237-2017-00749
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
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 Received02/17/2017
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: 02/21/2017 Patient Sequence Number: 1
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