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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); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 17-dec-2018, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 17-dec-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 who was implanted with an implantable neurostimulator (ins) for spinal pain. The reason for call was pt stated they had a recent operation on their back near the ins (pt confirmed not related to device) and during the operation they moved the pt's leads a little. Pt said they needed their stimulator "readjusted" (pss understood as reprogrammed). The patient was redirected to their healthcare provider to further address the issue. Pt said their hcp office told them to call mdt. Pt mentioned they had an appointment with hcp on (b)(6).
 
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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 Key12515634
MDR Text Key272880964
Report Number3004209178-2021-14276
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2015
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 Received09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/26/2014
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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