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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 Problems Break (1069); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194); Therapeutic Response, Decreased (2271); Neck Stiffness (2434); No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2014
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for rsd/causalgia-complex regional pain syn and spinal pain. It was reported that the patient had a loss of pain relief as well as headaches. The ins was explanted on (b)(6) 2018 as a result of the loss of pain relief but also to see if the headaches would dissipate after the removal. The patient inquired if they could get the explanted ins back. The caller was redirected to the appropriate department. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient on (b)(4) 2018. The patient indicated that they had a stimulator removed in (b)(4) after 4 unsuccessful years of having it implanted. They were very dissatisfied. No further complications were reported/are anticipated.
 
Manufacturer Narrative
Concomitant medical products: product id: 977a275 , serial# (b)(4), implanted: (b)(6) 2014, product type: lead. Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) via the rep. The rep checked with the hcp's office to obtain the results of the x-rays that were provided. The results of the x-rays could not be provided because the patient's records were no longer available at the doctor's office due to the doctor no longer being at the practice. The only information they could obtain about the x-rays was that both images were from the explant procedure. One image was after the leads were removed and the second image was at the very end of the explanting procedure. It was noted that there was not a manufacturer representative present at the explant procedure. No further information could be obtained. No further complications were reported or anticipated.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7787334
MDR Text Key117252846
Report Number3004209178-2018-18361
Device Sequence Number1
Product Code LGW
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date03/28/2015
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/01/2014
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: 08/15/2018 Patient Sequence Number: 1
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