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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Edema (1820); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099)
Event Date 06/12/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A consumer reported that after the implant procedure, the patient symptoms of leg pain, swollen feet, and foot pus were not improved. The patient's health care provider (hcp) told them that there was no effect and no way to improve the symptoms. The patient was currently in treatment in a local hospital and they had been given a pain killer. The patient did not have a 50 percent or more reduction in symptoms. The cause of the event was unknown and it was unknown if any troubleshooting was done. The patient wanted their symptoms to improve. The patient's indication for use is lower limb ischemic pain.
 
Event Description
Additional information reported the patient was implanted with spinal cord stimulation (scs) due to lower limb ischemic pain. It was unknown if the hospitalization was related to the patient's device or therapy, unknown if diagnostics or troubleshooting was done, unknown if actions or interventions were taken or planned, and unknown if the patient was receiving effective therapy. The patient's outcome also was unknown.
 
Event Description
The manufacturer representative reported the patient experienced pedal edema and foot suppuration (in addition to the leg pain) after the spinal cord stimulation implant on (b)(6) 2016. The patient was hospitalized and under observation at a local hospital after receiving anesthetics. If the state of the patient deteriorated, the patient will visit the doctor at the hospital in which the implantation was performed.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePRIMEADVANCED
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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5952275
MDR Text Key102589267
Report Number3004209178-2016-18959
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/14/2017
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/14/2015
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: 09/15/2016 Patient Sequence Number: 1
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