• 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, IMPLANTED (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, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Hematoma (1884); Laceration(s) (1946); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Scar Tissue (2060); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331); Reaction (2414); Tissue Breakdown (2681)
Event Date 01/05/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer regarding the patient. It was reported that the patient had a ¿reaction to the paddles i guess to the spine and had a series of spasms and ended up paralyzed. ¿ the patient stated that the paddles cut the vein in her spinal column, and had a series of spasms where she was given intravenous valium to control it. Again about one hour before she was going to be stood up for the first time, they could not get the valium to her quick enough and she ended up paralyzed. The doctor got her into emergency surgery and they only removed the paddles (at t12). The patient went to rehabilitation for paralysis in january of 2017. They had her rolled (log-rolled to the right-hand side) and heard a loud pop and the patient noted that it hurt. They did not know if it was scar tissue letting go (the patient noted that she is a scar tissue builder). The patient also noted that the battery was rolling around, especially when she sat in different positions, and it would pinch and hurt her. There was another pop with that pocket around april of 2017. On 2017-07-14, everything was healing up and the patient was walking pretty strongly, so they went to put the paddles back and a revision surgery was performed. They also went to do a pocket revision for the battery because the original pocket wasn¿t holding it anymore, and the implantable neurostimulator was too close to the patient¿s skin and pinching. Her back and butt have been swollen since surgery. There were no further complications reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient reported that they thought the reason they were paralyzed was because the rep was suppose to set up pump at 50 micrograms but instead it was set up at 24 micrograms (this information pertains to a related event regarding an infusion device the patient had implanted). No additional information pertaining to this event was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id: 977c165, serial# (b)(4), implanted: (b)(6) 2017, product type: lead. Concomitant medical products: product id: 8637-40, serial #: (b)(4), implanted: (b)(6) 2017, product type: pump. Product id: 8780, serial #: (b)(4), implanted: (b)(6) 2017, product type: catheter. 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
A healthcare provider and a manufacturer representative reported that the patient was experiencing muscle spasms and increased pain in the hospital following placement of a spinal cord paddle lead and intrathecal baclofen pump implant at the same time. When the patient¿s weakness symptoms in their lower extremities worsened it was discovered that they had an epidural hematoma. The patient was taken back to the operating room to have the paddle lead taken out of the epidural space and placed under the skin to save the paddle for later use when the patient recovered. As of (b)(6) 2017 the patient was regaining movement to their lower extremities. An mri was also performed on (b)(6) 2017 but the results were unknown. The patient was implanted for spinal pain and radiculopathy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (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 Key6284152
MDR Text Key100588181
Report Number3004209178-2017-01977
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
Device Model Number97714
Device Catalogue Number97714
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 Received01/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/15/2016
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: 01/27/2017 Patient Sequence Number: 1
-
-