Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97702
Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 11/01/2017
Event Type  malfunction  
Manufacturer Narrative
Other applicable components are:product id: 977a260, serial# (b)(4), product type: lead.Product id: 977a260, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - non-malignant pain/ chronic low back pain.It was reported that the patient had a previous implant replaced due to normal battery depletion and got a new implant.Patient reported that the implant was for delivering stimulation to lower back and when she left the hospital after implant she was only able to feel stimulation in her legs.Patient stated that apparently when they were putting it in when she was still under the influence of drugs she told them at the time that she was could feel stimulation in the lower back.Patient reported that she had no recollection of saying that and when she woke up she didn't anymore.Patient stated she had been back twice now to have it reprogrammed and they have not been able to get it in her lower back where she needs it.Patient stated stimulation did not go past her thigh and maybe she felt it in her front and a little bit in her ribcage.Patient stated not only does the implant not program correctly, but when she felt it, if felt very sporadic and she does not feel if consistently.Patient has stimulator on constantly and she guesses 50% of the time there's no stimulation.Patient stated she can be lying in bed at night and go to bed and she has stimulation, and it's supposed to be on both sides and now it's no longer on both sides.Patient stated with previous implant generally the left side stimulation was stronger than the right side but she has no stimulation on the left side now and it's only the on the right side.It was reported that the manufacturer's representative (rep) tried to reprogramming but it did not resolve the issue.Patient stated that when she is does not feel stimulation sensation, she uses the patient programmer to check the therapy status and the stimulator is still on and shows lightening bold in upper left hand corner.Patient stated that they guess there is a good possibility that the wires might have slipped and are no longer in the correct spinal area.Patient stated she thinks something happened with the wires.Patient services (pss) reviewed that from device records it shows patient had lead wires replaced with the new ones.Patient was redirected to healthcare provider (hcp).Patient reported that the rep made hcp aware that the patient was not getting stimulation where she needed it.No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep).It was reported that the patient would be meeting with another rep on (b)(6).The patient was sent for x-rays and they would be reviewed during the appointment.The patient had stated that she received stimulation on the left side in the rib area.No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep).It was reported that the patient would be meeting with another rep on (b)(6).The patient was sent for x-rays and they would be reviewed during the appointment.The patient had stated that she received stimulation on the left side in the rib area.No further complications were reported/anticipated.
 
Manufacturer Narrative
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).It was reported that the patient was not getting stimulation in their painful area (low back) and the stimulator isn't helping with their pain.The patient had an x-ray to confirm good lead placement.The healthcare provider (hcp) said that the leads are perfectly placed.The rep asked to see the x-ray, but they wouldn't pull them up.When the hcp office was asked to see the x-ray they told them that they didn't keep the images.The patient was programmed by 3 different people and were all getting bilateral stimulation to the tops of the thighs and bilateral ribs/stomach.No further complications were reported or anticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURESCAN
Type of Device
STIMULATOR, 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7045277
MDR Text Key93482165
Report Number3004209178-2017-24060
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109513
UDI-Public00643169109513
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 Other
Type of Report Initial,Followup,Followup,Followup
Report Date 12/01/2017
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? Yes
Device Operator Health Professional
Device Expiration Date01/28/2019
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/06/2017
Initial Date FDA Received11/20/2017
Supplement Dates Manufacturer Received11/20/2017
11/29/2017
11/29/2017
Supplement Dates FDA Received11/29/2017
12/01/2017
12/01/2017
Date Device Manufactured07/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age71 YR
-
-