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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Event Date 08/24/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3487a-45, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead. Product id: 3888-56, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 3487a-45, serial/lot #: (b)(4), ubd: 07-oct-2023, udi#: (b)(4). Product id: 3888-56, serial/lot #: (b)(4), ubd: 19-feb-2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that patient presented with swelling tenderness and pain at the stimulator pocket and cranial facial lead sites.  lead cut and left in patient to facilitate future channel/lead placement.  surgery performed where it was determined an infection was present. Stimulator removed and existing fascial leads cut and left in place to provide future access for new leads.  patient presented with tenderness, pain and swelling. Surgical procedure determined an infection was present. Stimulator removed as well as leads but not extensions.

 
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Brand NameSURESCAN
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 Key12377999
MDR Text Key268487512
Report Number3004209178-2021-13023
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2021
Device MODEL Number97702
Device Catalogue Number97702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/13/2019
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: 08/27/2021 Patient Sequence Number: 1
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