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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Purulent Discharge (1812); Fever (1858); Headache (1880); Unspecified Infection (1930); Pain (1994); Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Thrombosis (2100); Burning Sensation (2146); Hot Flashes/Flushes (2153); Chills (2191); Complaint, Ill-Defined (2331); Malaise (2359); Skin Inflammation (2443); Cognitive Changes (2551); Fluid Discharge (2686)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id 3487a-33, lot# v015619, implanted: (b)(6) 2008, product type lead. Product id 3487a-33, lot# v009632, implanted: (b)(6) 2008, product type lead. Product id 3887-33, lot# j0540948v, implanted: (b)(6) 2008, product type lead. Product id 3887-33 lot# v014071, implanted: (b)(6) 2008, product type lead. Information references the main component of the system. Other relevant device(s) are: product id: 3487a-33, serial/lot #: (b)(4), ubd: 29-nov-2010 ; product id: 3487a-33, serial/lot #: (b)(4), ubd: 10-jul-2010, udi#: (b)(4); product id: 3887-33, serial/lot #: (b)(4), ubd: 27-jul-2009, udi#: (b)(4); product id: 3887-33, serial/lot #: (b)(4), ubd: 25-oct-2010, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. The patient reported that as she was recovering from her recent battery replacement, she developed a sever rash around the site, within 3 days after surgery. The patient reported that they thought it was a tape allergy to the surgical mesh that was glued to the site and the tape surrounding it. The patient reported that she had never reacted to the tape before. The patient reported that she had very minimal draining. The patient reported that she had sent a photo of the rash and blisters to her healthcare provider (hcp) and the nurse told her to use some hydrocortisone cream on the rash, making sure it didn¿t go near the incision. The patient reported that she used it for 2 days after pulling the surgical mesh off (5 days after surgery) and the rash calmed down and stopped burning like fire, but was still there, so she just let the site be covered with a large gauze pad taping way away from the site with paper tape. The patient reported that on (b)(6) 2018 she had increased pain and swelling at the battery site and across her lower back where the wires were and on her spine where the lower electrodes were placed. The patient reported that she was feeling run down, then spiked a 104 fever. The patient reported that she went to her primary hcp on wednesday, right before closing. The patient reported that her fever was 102, there was no red rash, but he was sure she had an infection and called the patient¿s managing hcp. The patient reported that they tried to draw blood but were unable due to dehydration. The patient reported that her hcp saw her the next afternoon and upon viewing the sire, added more bloodwork to her orders and by then you could feel the wires which wasn¿t normal unless pushing hard and her spine hurt. The patient reported that the hcp said although it appeared to be an infection, there was no redness and it was too early for infections to show. The patient reported that he told her if there was an infection he would have to remove the new unit. The patient reported that on (b)(6) 2018 she had hot flashes/fevers and chills. The patient reported that she didn¿t have a thermometer but woke up completely soaked, with the bedding wet enough to ring out. The patient reported that she was delirious. The patient reported that a white puss bubble had showed up in the corner of the incision and she reached back and felt her hip, it was soaked through the gauze and my clothing and bedding had a 6 inch circle of drainage on them. The drainage was clear with no odor. The patient reported that she felt so bad that she called her hcp and the sent images of the site to the on-call hcp. The patient reported that he ordered antibiotics for her to start right away, thinking it was a stitch abscess. The patient reported that on (b)(6) 2018 her hcp called her into the office and she was very sick. The patient reported that emergency surgery was scheduled for the next day to remove the battery and possible wires because of the swelling on her spine. The patient reported that her white count was over 17,000 and her crp was 134 (anything over 5 is abnormal). The patient reported that in they found the battery sitting in a puddle of puss, the wires all infected to my spine and partially going up to the upper wires. The patient reported that there was a puddle of puss laying on top of her spinal column and where the electrodes were attached. The patient reported that they had to remove everything but my upper wires which were cut off 6" above the battery and they had to flush, clean and scrape out infected tissue. The patient reported that she was in the hospital for 3 days while they stabilized her blood sugar and blood pressure and ran strong antibiotics. The patient reported that when the cultures came back on day 3, it was (b)(6). The patient reported that it was a nosocomial infection acquired in the hospital prior to or during surgery. The patient reported that she was on antibiotics for 6 to 8 weeks by home infusion every 8 hours (cefazolin 2gm). The concern is osteomyelitis in her spine where the puss was found. The patient reported that her bloodwork is almost back to normal, and the rash from the new surgical sites has almost healed on (b)(6) 2018. The patient reported that she grew a blood clot below her pic line which was resolved with oral medications. The patient reported that her blood pressure was still being challenging as her body was trying to hear, she had spiked multiple times above her normal numbers and the hcp was trying to adjust her medications to try and get back into normal range. The patient reported that at this time even after she was healthy again, she was afraid to try to put the unit back in. The patient reported that prior to the replacement she used the ins every day 24/7. The patient reported that she took a few breaks to see how much it was helping and would quickly turn it back on. The patient reported that she loved it, the ins gave her a chance at a more ¿normal life. ¿ the patient reported that she was miserable right now, as the nerve pain that the stimulation blocked was back, plus the pain from the surgical sites and now nerve pain at the time where the pic line entered her arm and the headaches. The patient reported that there was a fear of more blood clots or her eye¿s bleeding from thinning her blood too much (diabetic retinopathy). The patient reported that she knew they couldn¿t tell where the infection came from, the tools in surgery, the actual or room, the battery itself, the staff. The patient reported that the infectious disease doctor said it grew so fast over the last 10 days before removal surgery that it must have been there from the get go growing all along. The patient reported that when the swelling first started she asked her hcp the different between the old battery and the new one, thinking perhaps she was reacting to something new in her body. The patient reported that she first felt the swelling and pain directly over the battery, where the infection was growing. The first pain was at the bottom of the battery, not at the incision site, but at the bottom of the pouch that was made for the battery to sit in. Then the whole b attery area swelled as the infection ran up the wires and across to my spine. No further complications were reported.
 
Manufacturer Narrative
Product id: 3487a-33, lot# v015619, implanted: (b)(6) 2008, product type: lead; product id: 3487a-33, lot# v009632, implanted: (b)(6) 2008, product type: lead; product id: 3887-33, lot# j0540948v, implanted: (b)(6) 2008, product type: lead; product id: 3887-33, lot# v014071, implanted: (b)(6) 2008, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Patient weight added. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider and consumer. It was reported from the healthcare provider that the reason for leaving lead in patient was due to surgeon preference. It was reported from the patient that they were still treating the infection. Hcp reported the infection was resolved. Patient reported the picc line removed but taking oral antibiotics for another 2-3 months. Patient reported it was suspected to be osteomyelitis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameINTELLIS
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 Key7492715
MDR Text Key107563614
Report Number3004209178-2018-10314
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
Device Model Number97715
Device Catalogue Number97715
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2018
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: 05/07/2018 Patient Sequence Number: 1
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