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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Malaise (2359)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp). The hcp reported that the patient was scheduled to be reprogrammed by a manufacturer's representative (rep) on (b)(6) 2017. No further complications were reported.
 
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) for non-malignant pain and failed back surgery syndrome. The patient reported that she needed to make an appointment to have her ins adjusted. The patient reported that she didn¿t feel the ins was working as well as it should. The patient reported that she thought she needed to have it adjusted to go higher on her back. The patient reported that she tried making adjustments using her patient programmer (pp) and tried groups a, b and c but that didn¿t help. The patient reported that she did have an adjustment right about a week after she got the device implanted since she couldn¿t do it the day of surgery. The patient reported that she was too sick and was in terrible pain right due to the surgery. The patient reported that the pain was gradually getting worse. No further complications were reported.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6993130
MDR Text Key103540004
Report Number3004209178-2017-22914
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 11/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
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 Received11/02/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/25/2016
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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