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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 Migration or Expulsion of Device (1395); Unintended Collision (1429)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Dizziness (2194); Sweating (2444)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 977a260, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional of a clinical study regarding a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain. It was reported that patient's pain was well managed by device until a fall in (b)(6) 2017 due to lost balance due to loss of feeling in their leg. Patient injured their foot/ankle and the foot/ankle pain has been resolving and returning to normal. Back pain started around midnight previous night, patient went to emergency department on (b)(6) 2018 with pain after experiencing sweats/dizziness, 10/10 pain, possible black out while at work due to pain. Patient's pain increases with pressure or flexing. X-ray impression showed mild lead migration from t9 to t10, no known injury to back, patient fell to knee 56 hours prior. Discharge diagnosis was muscle spasm since pain significantly improved with valium and ketorolac. Patient still reporting good pain relief for device indication. Patient had good pain relief in abdomen/groin (ilioinguinal pain is original device indication). Patient discussed lead migration a nd new acute low back pain with healthcare professional. Tpis, baclofen were planned for back pain/spasms. No further complications were reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from healthcare professional of a clinical study. It was reported that medications were given on (b)(6) 2018 and no other actions were listed. No further complications were reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) in a clinical study (sdy). It was reported that, on (b)(6) 2018, the patient received trigger point injections (tpi) in their right lumbar paraspinal and latissimus dorsi muscles. On (b)(6) 2018, they were having pain in the right, mid-back and more tpis were scheduled. On (b)(6) 2018, they had injections in the right infraspinatus rhomboids, latissimus dorsi, and triceps. The issue was noted to be resolved, without sequelae, at this time.
 
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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 Key7436489
MDR Text Key106162516
Report Number3004209178-2018-08189
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2017
Device Model Number97714
Device Catalogue Number97714
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 Received02/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/29/2016
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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