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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 Energy Output Problem (1431); Delayed Charge Time (2586)
Patient Problem Device Overstimulation of Tissue (1991)
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported via the manufacturer representative that the stimulator had never worked for her legs, but did work for her back. Anytime the legs got stimulation her ribs were stimulated intensely. It was noted that patient had fallen, but impedances were all within normal ranges. The patient was being referred for x-rays and was then going to be referred for surgery to have the leads taken out and replaced with a paddle lead. At the same time they wanted to replace the battery as it was taking 6+ hours to charge. Recharging statistics were pulled and showed the average ending charge level was 25%, the average recharge session was 43 minutes, the average recharge interval was 3 hours and the median coupling strength was 8.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11636208
MDR Text Key244486590
Report Number3004209178-2021-05716
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
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2018
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 Received04/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/07/2017
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: 04/08/2021 Patient Sequence Number: 1
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