• 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 97712
Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Patient Problems Cerebrospinal Fluid Leakage (1772); Emotional Changes (1831); Hematoma (1884); Incontinence (1928); Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Pain (1994); Perforation (2001); Neurogenic Shock (2265); Distress (2329); Complaint, Ill-Defined (2331); Numbness (2415); Spinal Cord Injury (2432); Paraplegia (2448); Ambulation Difficulties (2544); Foreign Body In Patient (2687)
Event Date 02/21/2017
Event Type  Injury  
Manufacturer Narrative
Corrected information: sex, date of birth. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id 977a260 lot# serial# (b)(4). Implanted: explanted: product type lead product id 977a260 lot# serial# (b)(4) implanted: 2017(b)(6) explanted: 2017(b)(6) product type lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a legal representative of the patient. It was reported that patient had a significant low back problems for a number of years, resulting in two surgical procedures in 2008 and 2012. The procedure in 2012 involved a fusion with hardware from l5-l3. As a result of the significant low back difficulties sustained by patient, patient suffered from chronic pain. In about the end of 2016, patient sought out the advice and treatment from healthcare professional for intractable back pain. Patient was recommended to underwent a series of epidural injection in the low back in an attempt to alleviate or release control of the intractable low back pain, but to no avail. Thereafter, patient was recommended by healthcare professional to the spinal cord stimulation trial to help predict the efficacy of the potential implant and to make sure patient would not suffer from any allergies or adverse reaction to the device. The trial was completed in late (b)(6) 2016 that patient experienced some pain relief and had no a adverse reactions. Patient had the implant on 2017(b)(6), where the ins was implanted on the right side and ran the leads towards the spinal cord and accessory nerves. The leads were supposed to be placed in the epidural space at or around the area of significant pain, at this point, the patient's low back or lumbosacral spine. Immediately after procedure and waking up from anesthesia, patient complained that they had no feeling/sensation in their lower legs. Patient was assured by healthcare professional and staffs that was expected from the anesthesia and there was nothing to worry about. Over the next approximately 6 hours, patient continued to complained of not being able to feel anything below their legs and was, in fact, incognizant of bowel and bladder at that point. After some time, healthcare professional finally agreed to transport patient to an emergency facility. At the emergency department, a ct scan quickly revealed that the leads had, in fact, penetrated and were wrapped around patient's spinal cord and that perhaps the dura of the spinal cord had been penetrated by the leads and a significant bleeding and perhaps a hematoma was able to be seen. It was verified that a significant spinal cord injury had been sustained from patient as a result of the implantation of the device and that emergency surgery was necessary. During the following surgical procedure, healthcare professional saw that the leads implanted earlier had, in fact, traversed the spinal cord to t9 and had penetrated the spinal cord on several spots, causing significant nerve damage, causing a hematoma which could not be evacuated, penetrating the dura to cause a durotomy with resulting leaking of spinal cord fluid and blood. As a result, patient sustained paralysis of their body below the waist, and had been rendered incontinent of bowel and bladder, and will not be able to walk again, wheelchair bound and these injuries are most likely than not going to be permanent in nature. As a further result of the injuries, patient had suffered and/or may suffer physical and mental anguish and pain, suffering, inconvenience, emotional distress, shock and injury to the nerves and nervous system. Patient had been and/or will be deprived of the ordinary pleasure of life. No further complications were reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead. 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 (hcp) reported via the manufacturer¿s representative (rep) a consumer who was implanted on (b)(6) 2017 h ad no feeling in their legs. A scan was performed the same day which showed the lead possibly went anterior and then posterior and created an air pocket, but there was no damage to the spinal cord. As a result the leads were explanted on (b)(6) but the issue still wasn¿t resolved with the consumer¿s status being noted as ¿alive with injury. ¿ due to this the consumer was being given a high dose of steroids in the hospital and was then going to physical therapy. No further complications were reported/anticipated. Relevant medical history includes non-malignant pain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6410894
MDR Text Key102907488
Report Number3004209178-2017-05754
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2017
Device Model Number97712
Device Catalogue Number97712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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 Manufactured01/26/2017
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: 03/16/2017 Patient Sequence Number: 1
-
-