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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 Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Charging Problem (2892)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Malaise (2359)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2018: (b)(4) : it was noted that the controller battery would drain out very quickly and the patient would have to charge it for 1-3 hours. Please review for manufacturing issue or design assessment collaboration. Concomitant products: product id: 97745, serial# (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient. It was reported that a software problem, or screen 99, error message was displayed on the controller. The patient stated that they charged their implantable neurostimulator (ins) to 60% on the day prior to the date of this report and turned it off afterwards because they didn¿t feel well. The patient mentioned that they were very unhappy about recharging the ins every day for an hour or more and having to charge the controller for one to three hours, as they only had to charge their previous implant once a week. It was noted that the patient saw a manufacturer representative on (b)(6) 2018 who told them they would love the new implant because it would take an hour to charge at most, but they would need to charge every day. However, the patient reported that on the date of this report, they were laying for two hours having excellent charging and the ins only charged up to 80%. It was noted that the software problem/screen 99 error message was resolved with troubleshooting, as the patient was able to successfully reset the device by removing the batteries and placing them back into the controller. It was also reported that the controller battery would drain out very quickly every day. The patient stated that this was very inconvenient and had no benefit to the therapy. In addition, the patient mentioned that they were sent home after surgery on (b)(6) 2018 and fell down from their bed, and had to call 911 to help because of the pain. The patient stated that therapy has helped the pain in their tailbone and across their hip since they removed the previous device. The patient was to follow up with their healthcare provider (hcp) to address any issues. No further complications were reported or anticipated. Indication for use is non-malignant pain.
 
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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 Key7245010
MDR Text Key99225911
Report Number3004209178-2018-02186
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
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2018
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 Received01/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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