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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 Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead. Information references the main component of the system. Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturing representative (rep) regarding a patient implanted for non-malignant pain. The rep reported that there was an out of range (oor) error showing on the patient programmer at 0. 3v. It was noted that the oor occurred while trying to increase stimulation. The rep stated that impedances were showing ¿xxx¿ on contacts 2, 3, and 7. Additional information was received on (b)(6) 2018. It was reported the suborbital lead had out of range impedances and was not delivering therapy. Reprogramming had been attempted but on (b)(6) 2018, the lead was partially explanted and replaced, which resolved the issue. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the manufacturing representative (rep) indicated that the patient initially informed them of the out of range impedances. They indicated that they do not know the date the patient first noticed the issue. The rep stated that the patient¿s device was delivering therapy at implant. No further complications were 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 Key7546305
MDR Text Key109352893
Report Number3004209178-2018-11946
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
Report Date 06/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2018
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 Received05/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/02/2017
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: 05/25/2018 Patient Sequence Number: 1
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