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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 Intermittent Continuity (1121); High impedance (1291); Unintended Collision (1429); Energy Output Problem (1431); Battery Problem (2885); Device Operates Differently Than Expected (2913); Impedance Problem (2950); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Neck Pain (2433)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient had 3 cervical peripheral nerve stimulation (pns) leads implanted to cover neck and shoulder pain.Prior to last week, the patient was receiving good pain relief in all of their painful areas of neck and shoulders.The patient had a loss of therapy and left neck pain.It was confirmed that there were no associated falls or traumas.Impedance tests showed electrode 3 was out of range (oor).After reprogramming, the patient could only feel stimulation from their left lead in their left should and nothing in their neck as they had before.An appointment with the health care provider (hcp) was going to be made for an x-ray to rule out lead migration.The other cervical pns lead was implanted in the right side of neck to cover their right side neck pain.It was confirmed that the coverage had not changed there, it was working, and provided right neck pain coverage without issue.The cervical pns lead implanted at the base of the neck to cover should pain had impedance testing return with normal limits and the patient could feel stimulation but now they felt it approximately 2 inches below their painful areas of the neck.Patient weight and medical history were asked but would not be made available.No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer.It was reported that since he had fall on cement, he has also felt a false surge go from his neck to the top of his head and behind the eye.It pulses and then it turns off and comes on again.This occurs when the patient is laying down.The patient stated that a rep had shut one of the leads off, but he was still getting the surging in the lead in the left side of his neck.No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient and a manufacturer representative (rep).It was reported that the patient continued to have a lot of muscle spasms and pain at the ins explant site.The healthcare professional put the patient on some new medication for the muscle spasms in their neck.No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received 2019-06-17.It was reported that it was confirmed that there was no infection.No further complications were reported/anticipated.
 
Manufacturer Narrative
Analysis of the ins ((b)(4)) found no significant anomalies.Below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a patient and a manufacturer representative (rep) reporting that the patient felt sudden surging stimulation (also described later as intense pulsing) in their stimulation area and then the battery loses power and needs to be charged.The patient did not know if the amplitude showed as increased on the patient programmer.It was reported that the patient did have a fall on the battery and they also noted that the pocket was swollen and tender to touch and the patient sometimes felt a ¿tearing¿ sensation in the pocket.The caller added that they checked the impedances and contact 3 was greater than 10,000 ohms, but 3 was not programmed.The patient had cervical/occipital leads.Technical services asked if the issue was positional and the rep stated no.It was reported that imaging had been done and the lead had not moved.The patient was on low dose programming.B1 450pw rate 30 amp 7.4 928 ohms, b2 450pw rate 30 amp 7.4 928 ohms it was reported that the caller attempted some range of motion testing and they were unable to replicate the issue today.It was reported that the doctor was taking the patient back for surgery to look for an infection.It was reported that the fall occurred in (b)(6) 2018 and the out of range impedances were found (b)(6) 2019.Additional information was received from the rep the next day reporting that the surgery was scheduled for (b)(6) and the plan was to remove the patient¿s old system entirely and to send it in for analysis.They were then going to implant a new system with 1x8 leads and a new rechargeable ins as long as the infection was ruled out from the swollen pocket.No further complications were reported/anticipated.
 
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Brand Name
SURESCAN
Type of Device
STIMULATOR, 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 Key7151287
MDR Text Key96122120
Report Number3004209178-2017-26720
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109483
UDI-Public00643169109483
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 Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2017
Initial Date FDA Received12/28/2017
Supplement Dates Manufacturer Received04/22/2019
04/24/2019
06/12/2019
06/17/2019
10/07/2019
Supplement Dates FDA Received04/24/2019
05/09/2019
06/17/2019
06/18/2019
10/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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