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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 97702
Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  malfunction  
Manufacturer Narrative
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). It was reported that the patient noted shifting of their device, that it was extremely close to their skin, implant was protruding 3/4th's of an inch out of skin so that the perimeter of the device could be seen. When patient moved in bed, rolled over, implant protruded out of the skin. Patient reported there was change in stimulation with the shifting of the device. Patient also stated that stimulation changed with different body positions, which they acknowledged could be normal. Patient was worried that the implant or lead had possibly disconnected and/or damaged. Troubleshooting was unable to be performed as patient did not meet with doctor yet and called for physician listings.   patient services directed patient to see healthcare provider (hcp) to address medical issues. The patient has appointment with doctor end of week.   see pe (b)(4) for the report of after surgery circulation was cut off to legs and feet were cold and blue.
 
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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 Key11807482
MDR Text Key253213572
Report Number3004209178-2021-07549
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,Followup,Followup,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/03/2019
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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