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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 Impedance Problem (2950)
Patient Problems Unspecified Infection (1930); Pain (1994); Discharge (2225); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Fluid Discharge (2686)
Event Date 02/07/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient via manufacturer representative, regarding patient's implantable neurostimulator (ins). Patient had a small blistered area seeping blood tinged discharge on the top of neck/base of head in the back near the occipital lead area. Patient stated she heard a pop and the area started to hurt. There were no known causes. Checked impedances and noted 0,1,4,7 are all over impedance. Patient was prescribed antibiotics. Reprogrammed lead and patient was satisfied with stim coverage. The issue was resolved. Hcp had no further information. Patient's weight was asked but unknown. No further complications were reported.

 
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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 Key9751435
MDR Text Key184334327
Report Number3004209178-2020-04038
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2019
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 Received02/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/22/2018
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: 02/25/2020 Patient Sequence Number: 1
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