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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Energy Output Problem (1431); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 05/02/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 97715 lot# serial# (b)(4) implanted: (b)(6) 2019 explanted: product type implantable neurostim ulator. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins). The reason for call was yesterday the patient picked up something and felt a pop. After that their stimulation changed and they had to contort their body to feel their stimulation. Pss documenting reported event. Patient had an appointment scheduled for (b)(6) 2021 to meet with their health care provider regarding this event. The patient said they had 19 surgeries over the past 20 years and they mentioned they had a revision a couple of years ago, patient services specialist believed that the patient was referring to having their two 97715's implanted on (b)(6) 2019. Patient made no allegations against longevity of any medtronic devices. Patient's reason for call was to contact a medtronic representative (rep); patient services specialist reviewed the role of the rep and redirected the patient to their health care provider. Caller was redirected to the healthcare provider (hcp).  .
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key11770598
MDR Text Key254016428
Report Number3004209178-2021-07154
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2020
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 Received06/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/28/2019
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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