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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 Erythema (1840); Unspecified Infection (1930); Malaise (2359); Swelling/ Edema (4577)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 977a290, serial#: (b)(4) implanted: (b)(6) 2017, explanted: (b)(6) 2021, product type: lead, product id: 977a290, serial#: (b)(4), implanted: (b)(6)2017, explanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 977a290, serial/lot #:(b)(4), ubd: 06-oct-2018, udi#: (b)(4) ; product id: 977a290, serial/lot #: (b)(4), ubd: 11-apr-2018, 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 non-malignant pain. It was reported that patient reported receiving a haircut on (b)(6) 2021 and the next day at the anchor site he noticed redness/soreness. Over a period of 5 weeks swelling increased at this site and to the left of the anchor. Reported feeling ill during this time. Only thing the patient can think happened is possibly cut at anchor site during haircut. Patient went to see hcp to assess the redness and swelling.   explant surgery was performed on (b)(6) 2021. Patient explained surgeon told him the stimulator was infected and had to pull the entire system out.

 
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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 Key12032576
MDR Text Key257198126
Report Number3004209178-2021-09671
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
Report Date 06/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2020
Device MODEL Number97702
Device Catalogue Number97702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/29/2019
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: 06/21/2021 Patient Sequence Number: 1
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