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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 Failure to Deliver Energy (1211); No Device Output (1435); Device Difficult to Program or Calibrate (1496); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Therapeutic Effects, Unexpected (2099); Malaise (2359)
Event Date 11/01/2015
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Other applicable components are: product id: pnma01411a004, serial# unknown, product type: recharger.
 
Event Description
Information was received from a patient who was implanted with a neurostimulator for non-malignant pain. The patient reported poor coupling with recharging. Since (b)(6) 2017 the patient¿s implantable neurostimulator recharger (insr) and patient programmer would not turn on the stimulator. The patient initially stated that their stimulation just turns off and they feel nothing. The patient is unable to turn the stimulation back on and their stimulator will not hold a charge. On the day of the report the patient stated that while charging their system there were 0 coupling bars showing and the implantable neurostimulator (ins) battery was blinking at the 25% mark. The patient tried using their patient programmer but it would not let them get to where they can even program it. The patient mentioned that since (b)(6) 2015 their belt does not provide good coupling. The patient stated that their use spanks because ¿the belt is stupid¿ and the belt was never going to work for them. The patient stated that they were charging right over the skin and tried switching from a sitting position to a lying position which gave the patient 4 bars. It was unknown if troubleshooting resolved the issue. The patient stated that they were only getting 4 bars after switching positions but would continue to work with it since they normally charge lying down anyway. The patient stated that they had not kept up with charging due to an unrelated surgery and they were not feeling good. The patient normally charges every night. The patient confirmed that the problem with the patient programmer was that they were not able to turn stimulation on using it, but it was reviewed with the patient that the ins automatically turns off when it is less than 25% full. It was reviewed with the patient to charge their ins back to at least 25% in order to turn the stimulation back on. No further complications were reported/are anticipated.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6453254
MDR Text Key102502189
Report Number3004209178-2017-06852
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 04/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2016
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 Received03/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2015
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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