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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 Diarrhea (1811); Purulent Discharge (1812); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Post Operative Wound Infection (2446); Alteration In Body Temperature (2682)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an spinal p ain. It was reported that the patient noted diarrhea, shortness of breath and light-headedness on (b)(6) 2019, which continued over the next several days. On (b)(6) 2019 the patient was very cold and noted pus coming out of their generator incision. They called the neurosurgery service and was taken by ambulance to the hospital. The patient was seen by their doctor¿s partner, who explanted their device on (b)(6) 2019 once the patient¿s blood pressure was under control as it was at 200/115 on admission per the patient. No known factors led or contributed to the issue. The patient¿s generator and lead were explanted due to infection and the patient was on iv antibiotics. It was reported that the patient would be sent home on antibiotics. The patient would be seen in four weeks to assess options of re-implanting their device. It was reported that the issue was resolved at the time of the report. The device would not be returned for analysis as the customer discarded it. The event occurred on (b)(6) 2019. No further complications were reported/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 Key8253857
MDR Text Key133253565
Report Number3004209178-2019-01123
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/30/2018
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: 01/16/2019 Patient Sequence Number: 1
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