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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, IMPLANTED (PAIN RELIEF)

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Unspecified Infection (1930); Reaction (2414); Fluid Discharge (2686)
Event Date 04/14/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Other applicable components are: product id 3777-60 serial# (b)(4) implanted: (b)(6) 2017 explanted:(b)(6) 2017 product type lead product id 3777- serial# (b)(4) implanted: (b)(6) 2017 explanted: (b)(6) 2017. Product type lead. 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.
 
Event Description
The consumer reported that he had to have surgery again because he had trouble. The patient stated that due to scarring from a previous spinal cord stimulation system they couldn¿t implant the current system in his spine so they did a peripheral for his shoulder. The patient noted that since implant one of his leads migrated and actually protruded through the skin twice and he had two surgeries to repair it. The patient mentioned it felt like something weird and he looked and could see some puss when he moved his shoulder and could see the whole lead slide out. The indications for use were spinal pain and cervical/neck.
 
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.
 
Event Description
Additional information was received from a manufacturer's representative (rep). The patient's weight was stated. The rep stated that they became aware of the revision on the day of the revision. The cause of the lead migration was due to infection following a reaction to the adhesive in the dressing. Then a reaction to the type of suture that was used, fiberwire. The situation has been resolved at this time. No further complications were reported.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6549264
MDR Text Key102631306
Report Number3004209178-2017-09781
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,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2017
Device Model Number97714
Device Catalogue Number97714
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 Received05/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2017
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: 05/05/2017 Patient Sequence Number: 1
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