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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 Electromagnetic Interference (1194); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)
Patient Problems Dyspnea (1816); Pain (1994); Burning Sensation (2146); Numbness (2415); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
Device available for evaluation: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Product id: 977a260, serial/lot #: (b)(4), ubd: 15-sep-2024, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 06-apr-2024, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that on (b)(6) 2021 the patient's child fell on their back where their leads were implanted.  following the fall, they had shocking and spamming around where their leads were. The patient turned off the battery for the night. They had turned it back on (b)(6) 2021 and shocking had subsided but they had a hard time taking a deep breath due to pain around the site. The patient was awaiting an appointment with their physician where they would be assessed for impedances and changing programs. The issue was not resolved at the time of report.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11333438
MDR Text Key233817706
Report Number3004209178-2021-02685
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 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2021
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 Received05/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/17/2020
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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