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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 Migration or Expulsion of Device (1395); Application Program Problem (2880)
Patient Problem Pain (1994)
Event Date 07/24/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 31-aug-2022, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 28-aug-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
A friend/family member reported that around (b)(6) 2021 the patient had fallen twice within 30 minutes, and then fell again on (b)(6) 2021.  since the fall in (b)(6) 2021, the patient had been experiencing a sharp penetrating pain that went from their back to their chest when they moved a certain way.  x-rays were taken because they thought the patient had broken a rib, but the results showed that the rib was not cracked.  the caller thought that one of the leads came loose.  on (b)(6) 2021, they tried to make changes to the settings and the controller displayed the settings not available message.  it was confirmed the ins had a 100% charge.  patient services reviewed to lower stimulation in other groups and/or programming changes.  they were redirected to the doctor to check the implanted devices.
 
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Brand Name
INTELLIS
Type of Device
STIMULATOR, 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 Key12288692
MDR Text Key265423270
Report Number3004209178-2021-12028
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/03/2021
Initial Date FDA Received08/06/2021
Date Device Manufactured09/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age51 YR
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