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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problem Human-Device Interface Problem (2949)
Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Complaint, Ill-Defined (2331); Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/11/2016
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Patient reported that the initial implant was to be replaced due to normal battery depletion in (b)(6) of 2016 but they could not put it in the same pocket or something like that/they put in battery couldn't do it, they couldn't get the battery to fit in the old pocket so they made new spot and then got (b)(6). Patient could not clarify what the exact issues was. Patient added the device eventually did get implanted, but patient developed (b)(6) in 2017, kept getting sick, was hospitalized, almost died and the whole system had to be removed later in (b)(6) 2017. Patient waited 6 months to get the device which is currently implanted. Device status was unknown. The doctor who did the surgery in (b)(6) of 2016 passed away and the office will not have any additional information.

 
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Brand NameSURESCAN
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 Key10700327
MDR Text Key212061136
Report Number3004209178-2020-18224
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 11/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/14/2017
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 Received11/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/14/2016
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: 10/19/2020 Patient Sequence Number: 1
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