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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 Failure to Deliver Energy (1211); Unintended Collision (1429)
Patient Problems Hemorrhage/Bleeding (1888); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
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 a neurostimulator for non-malignant pain. It was reported that the patient fell on her side three or four days after the implantable neurostimulator (ins) was implanted on (b)(6) 2019 noting that her incision ¿bled the tiniest bit of blood. It cracked the edge of the scab. ¿ the patient stated that she has been noticing her stimulation kept turning off randomly and going to 0. 0 ma. The patient couldn¿t feel the ¿buzzing¿ when she checked her stimulation settings before bed. The patient added that she could feel the difference when the stim was set to 0. 0ma. A log was kept when the patient¿s stimulation would turn itself down to 0. 0ma, noting that it occurred on the following dates: (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, and (b)(6)2019. It was noted that the stimulation hadn¿t turned itself down to 0. 0 ma in two days. This issue was not happening in specific positions or different times of the day and the patient confirmed that adaptive stimulation was turned on for programs 1 and 2 which they increased to 3. 0 ma. The patient was advised to turn adaptive stim off and monitor if the issue persisted. In the end, the patient was redirected to follow-up with their healthcare professional (hcp) to have ins checked but the patient stated that hcp told them that the ins would be okay. There were no further complications reported or 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 Key9527632
MDR Text Key173095267
Report Number3004209178-2019-24496
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 12/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/10/2019
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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