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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 Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 37714, lot# / serial# : (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. 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 she has been recharging every 3 weeks since (b)(6) 2021 then one day pt was not able to connect to her devices to charge. Pt reported seeing a message with a dr symbol but pt could not provide any code information from that screen. Pt stated that hcp office told pt to contact a field rep to have her ins checked. Troubleshooting was unable to be performed as pt does not have her equipment with her. No symptoms were reported.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12447996
MDR Text Key270594655
Report Number3004209178-2021-13588
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,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2015
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 Received09/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/28/2014
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: 09/09/2021 Patient Sequence Number: 1
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