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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 Migration or Expulsion of Device (1395); Energy Output Problem (1431); Battery Problem (2885); Insufficient Information (3190)
Patient Problems Cerebrospinal Fluid Leakage (1772); Chest Pain (1776); Emotional Changes (1831); Fatigue (1849); Headache (1880); Pain (1994); Seroma (2069); Therapeutic Effects, Unexpected (2099); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Malaise (2359); Depression (2361)
Event Date 12/14/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 31-aug-2022, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 31-aug-2022, 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) via a manufacturer¿s representative (rep). The rep reported that during a post-operative visit to the physician¿s office the patient had headache pain that increased with stimulation was activated. The healthcare provider (hcp) explained that the patient had a small csf leak and the patient needed to apply pressure to the area, drink liquid, caffeine and rest. A blood patch alternative was discussed. The patient called on the day of the report stating that they still had a headache and with the stimulation deactivated have a bit of relief since monday. The rep reported that the patient had edema in the pocket and decrease the one in the anchoring area. The rep reported that it was determined that wouldn¿t open it and wait. Additional information was received from a hcp via a rep on 2018-12-27. The rep reported that the patient had uncomfortable stimulation and pain in the implant area. The rep reported that the patient was developing a seroma. The rep ran an impedance test and images. The rep reported that when the images were done, the hcp saw lead migration. The rep reported that lead migration and seroma occurred in the process of cicatrization. The rep reported that there was an increase in post implant pain. The rep tested the controller and recharger and the recharger was okay. The rep also reported that there was fast batter discharge. The rep tested charging procedures and it was okay. The system was explanted. Additional information was received from the hcp on 2018-12-28. The hcp reported that the problem was that the ins was discharged in 4 days and no rep would answer the patient¿s calls. The hcp reported that a dural puncture was done, forced fluids, use caffeine and bed rest as actions/interventions taken to resolve the csf leak. The hcp reported that there was no edema. The hcp reported that the patient complained of a strange sensation after turning on the ins. The hcp reported that the patient needed reprogrammed by a tech. The hcp reported that a blood patch wasn¿t done yet as the headache was resolving. No further complications were reported.
 
Manufacturer Narrative
Product id 977a260, serial# (b)(4), implanted: (b)(6) 2018. Product type lead ; product id 977a260, serial# (b)(4), implanted: (b)(6) 2018. Product type: lead; product id 977a260; serial# (b)(4), implanted: (b)(6) 2018. Product type: lead; product id 977a260; serial# (b)(4); implanted: (b)(6) 2018. Product type: lead. Correction: device mfr date of previous report should be 2018-12-17. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient reiterating that after their device was implanted they began having new pain (body pain). Shortly after implant the ins was turned off. The patient called a manufacturer representative (rep) and the rep had noted that it may be too soon after implant to charge and redirected the patient to follow-up with their healthcare provider (hcp) for the ok to charge. The patient reviewed that they talked with the hcp and was able to charge the ins, but the ¿new pain¿ continued. The patient ended up going to the doctor on (b)(6) 2018, and after the pain continued they went to the emergency room (er). The rep noted that the er gave them something for the pain, but hen the pain returned and they called 911 and took an ambulance to the hospital. It as reviewed that the ins system was removed and the hcp found a cable ¿loose¿ or not in it¿s place. The caller noted that a rep was present with removal and the rep would be sending the system back to the manufacturer for analysis. It was reviewed that once the ins was removed the new pain stopped and the patient was only left with their pre-existing pain that they were implanted for. The body pain began on (b)(6) 2018, it was indicated that the ins went dead and was not given the ok to charge. The ins system was removed on (b)(6)2019, where the loose lead was discovered. No further complications were reported/anticipated.
 
Manufacturer Narrative
Product id 97791, serial# unknown. Product type accessory; product id 977a260, serial# (b)(4), implanted: (b)(6) 2018. Product type lead; product id 977a260, serial# (b)(4), implanted: (b )(6) 2018. Product type lead, product id 977a260, serial# (b)(4), implanted: (b)(6) 2018. Product type lead, product id 977a260, serial# (b)(4), implanted: (b)(6) 2018. Product type lead. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 803, the if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative (rep) on (b)(6) 2018. The explant date was on (b)(6) 2019. The patient complained of **illegible** after 2-3 days and then **illegible**. There was not normal battery depletion. It was device-related, **illegible text**. There was not an infection. There was not a patient injury and the patient recovered without sequela. No further complications were reported/are anticipated.
 
Manufacturer Narrative
Product id: 97791, serial# unknown, product type: accessory; product id: 97791, serial# unknown, product type: accessory; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from legal. It was reported that the patient was implanted on (b)(6) 2018 and discharged the same day with a moderate headache. After they were discharged, they began to experience strong headaches and problems with the neurostimulator battery. On (b)(6) 2018, they contacted a manufacturer representative (rep) after they became aware the neurostimulator had run out of battery. The rep replied that the patient needed to wait until their next appointment with the doctor to solve the battery problem. The patient called the doctor¿s office to inform them of the problem with the stimulator. Several hours after this, the rep called the patient and gave them instructions, through the phone, on how to recharge the equipment. The patient¿s headaches continued to worsen and they went to the doctor¿s office on (b)(6) 2018. Adjustments were made to the neurostimulator and they were prescribed medications for the pain. Since the pain was unbearable, they went back to the doctor¿s office on (b)(6) 2018 and had a sonogram performed and they were again discharged home with medications. On (b)(6) 2018, the patient¿s headache continued to worsen and they were also having chest pain. They went to the emergency room and was given several medications, including morphine, to handle the pain they were experiencing. The pain did not subside, but they were discharged on (b)(6) 2018. On (b)(6) 2019, the patient had to be transferred by ambulance to the emergency room. They were then admitted to perform a surgery to remove the neurostimulator as it was defective and it malfunctioned. It was reported that the stimulator failed to perform as safely as expected and failed to match the average quality of like products and failed to provide adequate instructions/warnings of risks involved in using the product. The patient experienced and was still experiencing intense mental suffering, anguishes, and physical damages. They experienced unbearable and severe headaches that radiated into their back, had chest pain, and general malaise. The pain was disabling and prevented them from having an adequate quality of life. The patient suffered and still suffered loss of sleep, anxiety, emotional distress, depression, and the ability to enjoy life.
 
Manufacturer Narrative
The returned ins and two leads were subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing. The returned devices passed all testing in the laboratory and no anomalies were identified. Analysis of the 97791 bumpy anchor identified that the anchor migrated. Fdc and fdr codes apply to the anchor. 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 the patient on 2019-feb-20. The patient called back to check the status of the analysis letter. Patient services reviewed the current status of analysis. No further complications were reported/are anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient on 2019-may-15. The patient received the device and would like to know when to expect the letter. Patient services reviewed information. No further complications were reported/are anticipated.
 
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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 Key8212415
MDR Text Key131921327
Report Number3004209178-2019-00143
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2018
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: 01/03/2019 Patient Sequence Number: 1
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