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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)
Event Date 09/05/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 977c165; serial# (b)(4), implanted: (b)(6) 2019, product type lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that the patient fell through a sun rotted chair and the patient had an increase in post-implant pain, the upper incision for the lead partially split open, and there was some bleeding. There were no signs of infection. The hcp didn't want to stitch up a possibly infected area, so they put steristrips on, but they came off the day of the report. The patient had no complaint about the stimulator and said it was working fine with no complaints about the device/therapy. No further complications were reported. Additional information was received from the rep. It was reported that the spinal incision was split open more and looked infected. Patient went to the hospital and the device was explanted on (b)(6) 2019.
 
Manufacturer Narrative
Product id: 977c165, serial# (b)(4), implanted: (b)(6) 2019, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. It was reported that the device would not be returned as it was discarded.
 
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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 Key9147095
MDR Text Key161792029
Report Number3004209178-2019-18856
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 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/14/2020
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 Received10/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/22/2019
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: 10/02/2019 Patient Sequence Number: 1
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