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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 Impedance Problem (2950); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 09-mar-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer representative reported that during implant the lead was found to have out of range values on electrode 7. The lead was tested in the wireless external neurostimulator and was not viable and out of range. It was decided to replace the lead and the replacement resolved the issue. The indication for use was non-malignant pain. No patient symptoms reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider. It was reported that the cause was unknown. No further complications were reported or anticipated.
 
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 Key7753465
MDR Text Key116899102
Report Number3004209178-2018-17481
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
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 Received09/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/17/2018
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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