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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 Break (1069); High impedance (1291); Unintended Collision (1429); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a275, lot#: 0208639878, implanted: (b)(6) 2014, explanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 06-aug-2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient had a fall on (b)(6) 2020 and told the clinic that the spinal cord stimulation (scs) was no longer working properly. The patient experienced a loss of efficacy. The event resulted in an unscheduled clinic/office visit. The device was interrogated and all impedances were over 10,000 ohms. The lead fractured. The lead was explanted and replaced on (b)(6) 2020. The outcome was resolved without sequelae.
 
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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 Key12510135
MDR Text Key272682314
Report Number3004209178-2021-14200
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2015
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 Received09/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/05/2014
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: 09/21/2021 Patient Sequence Number: 1
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