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); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Aneurysm (1708); Arthritis (1723); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Loss of Range of Motion (2032); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Thrombosis (2100); Urinary Tract Infection (2120); Weakness (2145); Dizziness (2194); Myalgia (2238); Stenosis (2263); Therapeutic Response, Decreased (2271); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Disc Impingement (2655)

Event Date 03/16/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient.Product id 97754, serial# (b)(4, )product type: recharger.Product id 7495-51, serial# (b)(4), implanted: (b)(6) 1994, product type: extension.Product id 3550-29, lot# n521737, implanted: (b)(6) 2015, product type: accessory.Product id 3708360, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id 3587a, lot# l33119, implanted: (b)(6) 1994, product type: lead.(b)(4).

Event Description

It was reported that the patient could hardly walk.Her left leg did not move and when she was up on it the foot swelled and the back of the leg was hurting.This started happening on (b)(6) 2015.The patient was taking medication for that and a nurse from home health was going to the patient.It was noted that the patient went to the emergency room (er) on (b)(6) 2015.It was later reported that the ins was "doing its job." however, after the ins was implanted, the patient had experienced "sticky" bowl movements (bm) and the patient did not always know they had a bm.There was also pain in both legs below the knee.The problems were "getting worse." the patient was also having bowel and bladder issues.The patient had had multiple previous ins replacements, but never a reaction like this.But other than the leg pain below the knees they felt good.These symptoms occurred following the replacement.It was noted that it felt good while sitting, but movement caused the leg pain.The patient also wanted to contact manufacturing representatives (rep) to ask if the bm issue was due to the ins or if it was something else.They also wanted to have the device checked.They were scheduled to meet a rep on (b)(6) to check the stimulator.Additional information received from the consumer reported she had not been able to walk because her left leg would not move.She had to lay down 90 percent of the time because of the pain which went down both legs and the patient had pain her back and her stomach and had to take pain medications.A manufacturer's representative (rep) was present at the implant surgery.On (b)(6) 2015, the patient went in and they relocated her implantable neurostimulator (ins) at the replacement surgery and now she could walk.A rep was also present at this surgery.No traumas or falls were related to this issue.Relevant medical history included spinal pain.

Event Description

Additional information received reported that the patient was asked about their surgery last (b)(6) 2015 but they did not know if a new stimulator was implanted or if the device they had was moved to a new site.The consumer stated that their insurance forms showed that they paid for a new battery.It was reported that they saw a healthcare provider (hcp) in january and it was stated that the patient was doing well.The patient agreed to the hcp's statement and reported that they only needed to go back if they needed assistance or had concerns.

Manufacturer Narrative

Other applicable components are: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 1994, product type: extension.Product id: 3550-29, lot# n521737, implanted: (b)(6) 2015, product type: accessory.Product id: 3708360, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3587a, lot# l33119, implanted: (b)(6) 1994, product type: lead.

Event Description

Additional information received reported that the patient had a complaint of back pain.There was a report that the patient had symptoms of being dizzy.The healthcare professional (hcp) reported that the patient was put on pain medication and symptoms improved.It was reported that the symptoms were constant and worsening.The patient reported that they had symptoms of left lumbar left leg pain, chronic left leg pain, and weakness walking with a cane.There was a report that the patient had a limp.They had a pain of 9 on a scale of 1 to 10.In the patient's back, the patient had diffuse lower lumbar tenderness.There was a report that there was differential diagnosis of back pain, lumbar strain, abdominal aortic aneurysm, disc herniation, sciatica, spinal stenosis, and urinary tract infection.An ultrasound reported that there was no evidence of deep venous thrombosis identified in left lower extremity.During a follow up, there was a return of the extremity weakness, abdominal pain, inability to ambulate, control their bowels, bladder or any other concerning symptoms.During the re-examination, the patient had pain but had not received their iv pain meds yet.The patient felt greatly improved.They felt like they were at their baseline.Additional information reported lower left extremity pain for possible clot.The pain level was at a level of 6 on a scale of 1 to 10.There was a report of lower extremity pain, knee pain, and chronic back pain.There was a report that they were unable to ambulate very well and they drag their left lower extremity when they walk with a cane.There was a report of muscle pain.In a general report, there was no acute distress but the patient was unable to wiggle their toes on their left lower extremity.They could not dorsiflex or plantar flex their left ankle.They could not lift their left lower extremity up off the bed and the patient was tender to palpation along their left popliteal region left calf and left foot.An ultrasound of the left lower extremity reported that there was normal flow, compressibility, and venous waveforms were present in all the deep venous segments.No clot was seen within the deep veins.A return of symptoms worsening was reported.A re-evaluation reported that the patient was able to ambulate with their cane.They do walk with a mild limp which was noted to be their baseline.After they received their pain medication, they were now able to move their left lower extremity.

Manufacturer Narrative

Other applicable components are: product id: 3587a, lot# l33119, implanted: (b)(6) 1994, explanted: (b)(6) 2015, product type: lead.Product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 1994, product type: extension.Product id: 3550-29, lot# n521737, implanted: (b)(6) 2015, product type: accessory.Product id: 3708360, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Further updates regarding the events captured in manufacturer reports #3004209178-2016-06329 and #3004209178-2016-04575 will now be captured in manufacturer report #3004209178-2016-01647.(b)(4).

Event Description

Additional information received from the consumer on (b)(6) 2015 reported that it had become sore at the implantable neurostimulator (ins) site.On (b)(6) 2015, a manufacturer representative noted they had spoken with the patient the week prior ((b)(6) 2015) and the manufacturer representative was scheduled to meet with the patient on (b)(6) 2015.The consumer reported on (b)(6) 2016 that the implantable neurostimulator (ins) had been implanted backwards, which was wrong, and as a result the device was removed.Additional information received from the consumer on 10-mar-2016 reported that the patient had a battery replacement on (b)(6) 2015 and another eight months later ((b)(6) 2015); the patient was wondering whether the first battery was not good or whether a mistake was made by the healthcare professional.Additional information received from the consumer on 22-mar-2016 reported that the patient was unsure of what went wrong after the battery replacement on (b)(6) 2015, but she had to go back again on (b)(6) 2015 to correct or replace the battery.Additional information was received from the consumer on 31-mar-2016 clarifying the reported event; the patient noted "yes" and "(b)(6) 2015 [and] again (b)(6) 2015" when asked whether there was "a device concern, change in therapy, etc." symptoms related to the reported product problem included pain, the inability to walk/sit/stand, and needing to lay down most of the time; the patient also reported that the device was working now and it relieved the pain.Additional information received from the consumer on 17-may-2016 reported that the patient's battery correction on (b)(6) 2015 was because the ins would not stay in place.She began having issues after the (b)(6) 2015 surgery; she could not walk or stand, she could only sit up for a short time, and her leg would drag if she tried to walk as a result of the surgery.The patient also stated she was better now and still recovering.It was further reported that the patient was able to walk better and sit longer after a healthcare professional corrected the battery problem, but the patient had to take pain pills.She further stated that she never had to [take pain pills] until a healthcare professional had made a mistake on (b)(6) 2015.Additional information received from the consumer on 31-may-2016 reported that there were issues getting the battery started at the time of the previously reported issues; it was noted that multiple manufacturer representatives were made aware of this and were all there in 2015.The consumer reported that the lead revision done (b)(6) 2015 resolved the issue the patient had walking; the patient was able to walk again.It was noted that the manufacturer's records indicated surgical revision occurred on (b)(6) 2015, not the date the patient provided for the lead revision ((b)(6) 2015).The patient further reported that she still had pain; this was the only thing that had not resolved since the revision.She had this pain since (b)(6) 2015, and the patient was currently taking oral pain medication for the pain as of (b)(6) 2016.

• 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: 5413883
• MDR Text Key: 37611041
• Report Number: 3004209178-2016-01647
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2016

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: 12/28/2015
• 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: 01/11/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/01/2016; 05/23/2016; 06/29/2016
• Date Device Manufactured: 02/05/2015
• 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: 00072 YR