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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 97714
Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Undesired Nerve Stimulation (1980); Anxiety (2328)
Event Date 07/02/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2016. Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 03-nov-2019, 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 spinal pain. It was reported that patient had sinus surgery on (b)(6) 2021. States ever since stim is not in same area. Suspected lead migration. Patient needs to establish care with an hcp. Get x-ray. Meet with the hcp and the manufacturer at same time. Patient was implanted in texas. Lives in an rv in michigan right now. Cannot help until established patient with hcp.

 
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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 Key12307623
MDR Text Key266024139
Report Number3004209178-2021-12238
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,Followup
Report Date 09/10/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/14/2016
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/20/2015
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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