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

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

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.

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.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, 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 Key: 6284152
• MDR Text Key: 65999325
• Report Number: 3004209178-2017-01977
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• 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 Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2019
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR