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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 Unspecified Infection (1930); Inflammation (1932); Fluid Discharge (2686)
Event Date 01/28/2020
Event Type  Injury  
Manufacturer Narrative
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 timul neurostimulator (ins). It was reported that the incision area was inflamed and oozing. Antibiotics were given, but the problem was not resolved. The patient had an infection in the area of the device. The hcp performed a "clean out" procedure and the implant remained intact. The issue was not yet resolved. No further complications were reported.
 
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 infection was not resolved. Rep reported they learned this morning that the patient's stimulator implant was explanted and the would try re-implanting in a few months.
 
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 received from the rep indicated that the hospital discarded the explanted device. 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 Key9700232
MDR Text Key178797534
Report Number3004209178-2020-03164
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,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2020
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 Received03/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/29/2019
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: 02/12/2020 Patient Sequence Number: 1
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