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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Battery Problem (2885)
Patient Problems Pain (1994); Scar Tissue (2060); Sleep Dysfunction (2517); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 3888-56, lot# v433259, implanted: (b)(6) 2011, explanted: (b)(6) 2016. Product type: lead, product id 3888-45, lot# v760959, implanted: (b)(6) 2011 explanted: (b)(6) 2016, product type lead section d information references the main component of the system. Other relevant device(s) are: product id: 3888-56, serial/lot #: (b)(4), ubd: 11-mar-2014, udi#: (b)(4); product id: 3888-45, serial/lot #: (b)(4), ubd: 23-jun-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).  it was reported that the pt said in 2016 they had to go to a plastic surgeon to take care of some "tenting" of their wires. Pt said a manufacturing representative (rep) was in the operating room to make sure the wires were connected properly. Pt then said they never used ins again. Additional information was reported that the patient noted the ins was on the right side of their back and "it shifts", as pt said they must have so much scar tissue in there from the previous surgeries where ins was replaced after running out of battery. It was reported that ins was bothering them. Pt clarified the ins hurt and said it was "sticking me through the skin". Pt said sometimes they didn't notice it, but other times when sitting down the ins was really uncomfortable, and would be hard to sleep on their right side. Additional information was reported that the patient does not know the cause. The patient had not changed her activity levels or her programming. Pt stated that there were no other factors that 2) what steps were taken - pt had to have plastic surgery 4-5 years ago. Medtronic was standing by for the procedure. The procedure was urgent has the tenting issue been resolved by the plastic surgeon. The patient's ins is currently dead and cannot be restarted. Pt stated it has become painful in her back it is difficult for her to sit upright in a chair that is not upholstered. Pt cannot sleep on her right side. Pt has an appt with a surgeon on thursday (b)(6) 2021 to discuss removing the ins.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11739458
MDR Text Key263418988
Report Number3004209178-2021-06848
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2016
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/18/2015
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: 04/28/2021 Patient Sequence Number: 1
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