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

Model Number 97714

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Edema (1820); Swelling (2091); Urinary Retention (2119); Hernia (2240); Complaint, Ill-Defined (2331); Numbness (2415); Ambulation Difficulties (2544); Constipation (3274)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant product: product id 97791, lot # n592737, implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type accessory; product id 39286-65, serial # (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type lead.(b)(4).

Event Description

The healthcare provider via a manufacturer representative reported that during recovery in the post-anesthesia care unit (pacu) after implant the patient had pain in their abdomen on both sides equally and symmetrically.There were unable to determine the cause of the abdominal pain.The patient had been lying prone on a jackson spine bed with padding.There was padding in the same area that the patient complained the pain was at.It was noted that the patient was larger and also had a large umbilical hernia.The physician did not think that the lead was causing the issue because the stimulator was turned on in pacu and 2 programs each generated stimulation in the patient's back only reaching amplitudes of 3.0v.The patient requested that the stimulator be removed sometime in the middle of the night following surgery.The abdominal pain was not resolved at the time of the report even after the stimulation system was removed and it was noted that the physician only wanted the patient to turn the stimulator off.The patient was initially supposed to be an overnight stay at the hospital for evaluation.The patient was indicated for spinal pain.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from a healthcare provider via a manufacturer representative reported that the cause of the pain was undetermined but the doctor believed it was dorsal root irritation.The patient demanded to have the lead removed after the implant.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the healthcare provider (hcp) reported that a patient exam occurred on (b)(6) 2016.Following the explant of the lead and the generator in the left buttock, an abdominal and pelvic ct image was performed for abdominal pain.There was residual gas present within the spinal canal with mild effacement of the thecal sac visible from t9 through t11.Small amounts of gas were present within the soft tissues extending from the spinal canal to the subcutaneous fat overlying the left buttock.No soft tissue fluid collection was seen.Extensive postoperative changes in the lower part of the spine appeared unchanged.The left pedicle screw at l4 from prior to the implant appeared to extend into the l3-l4 disc space.The ct was noted to be limited due to absence of contrast.No acute inflammatory changes or fluid collections were seen.Mild bibasilar subsemental atelectasis was present, with the left being greater than the right.No pleural effusion was seen.The gallbladder was surgically absent without bile duct dilation.Small pancreatic calcifications were present.A lipid rich adenoma measuring 17 millimeters was present within the right adrenal gland.The left adrenal gland appeared normal.Calcified granulomas were seen within the spleen.Moderate plaque was present within the abdominal aorta and arteries without aneurysm formation.A fatty umbilical hernia was again seen without evidence of inflammation.Mild segmental thickening of the colon was probably due to limited distention.Distended regions appeared normal.No paracolic inflammatory changes or bowel dilation were seen.An mri was then performed without and with intravenous contrast on (b)(6) 2016 for continued severe pain after removal of the thoracic stimulator.There was no evidence of acute fractures or significant losses of vertebral body heights.There was normal alignment of the vertebral bodies and posterior elements.There was mild dextroconvex curvature of the lower thoracic spine and bone marrow signal was within normal limits.Disc spaces were fairly well preserved.No intrinsic signal abnormalities were seen throughout the thoracic spinal cord.There was no evidence of disc herniations, spinal canal stenosis, or neural foraminal narrowing.There was mild edema throughout the posterior paraspinous soft tissues on the right at the t10 level.This was maybe related to the recent spinal cord stimulator placement.There was mild cervical spondylosis with the disc osteophyte complexes at c4-c5, c5-c6, and c6-c7.This resulted in mild spinal canal narrowing at these levels.Overall, there was no mri evidence of disc herniations, spinal canal stenosis, or neural foraminal narrowing.There was no evidence of epidural abscess.There was mild edema within the posterior paraspinous soft tissues on the right at the t10 level that was possibly related to the recent spinal cord stimulator placement.There was pain/swelling/numbness in the abdomen, especially in the lower quadrants, but no injury had occurred there.The abdomen was noted to have been soft and non-tender prior to implant.It was noted that, while attempting to pass the electrode, it kept shifting to the left and right.After a bit more of the lamina was opened and a thick band of tissue was found, the laminectomy was carried out up through t9 and a portion of t8 and the electrode finally stayed midline.Postoperatively, he complained of abdominal pain.The patient had not gotten his methadone dose for about 36 hours, nor his dilaudid.The cause of this, according to the doctor, represented either stretching of the dorsal ganglia or from the thecal sac from placing the spinal cord stimulator electrode.The patient, though not visibly improved, was brought to the floor and then brought back to remove the system.It was noted that the abdominal pain had not been controlled on medications.He was also having some urinary retention that required straight catheterization.He had not passed flatus and he was not ambulating.The ct was ordered, which was negative.The mri was ordered and done under general anesthesia.The patient was not able to tolerate this.On (b)(6) 2016, post-op day 2, he continued to have high levels of pain that was localized in the bilateral lower abdomen.He had not yet had a bowel movement and was not yet ambulating.On (b)(6) 2016, he was still requiring straight catheterization for urination.His pain was much improved and was passing flatus, but had still not had a bowel movement.The mri was completed and was negative.On (b)(6) 2016, he was urinating without difficulty.He was recommended subacute rehabilitation, of which he refused, and he was then discharged home to follow up with the doctor in 2 weeks.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5422229
• MDR Text Key: 37963049
• Report Number: 3004209178-2016-01887
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2016

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 Date: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2016; 04/21/2016; 05/19/2016
• Date Device Manufactured: 11/04/2015
• 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: 00067 YR