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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 Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Undesired Nerve Stimulation (1980); Neuropathy (1983); Pain (1994); Therapeutic Effects, Unexpected (2099); Vertigo (2134); Tingling (2171); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Electric Shock (2554)
Event Date 08/28/2018
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 patient via manufacturer representative, regarding patient's implantable neurostimulator (ins). It was reported that patient had a fall and when she fell she hit the battery site, patient woke up in the middle of the night with horrible pain. Patient was advised to consult with doctor. Patient's weight was asked but unknown. No further complications were reported/anticipated. Additional information was reported that the patient is looking to meet with a manufacturing representative (rep) because their stimulation in causing terrible pain and the patient is suffering. The patient reported that the stimulation changed after her fall two months ago. The patient sated now the stimulation is going down her arm even when she turned off the stimulation. This was considered a sudden change in stimulation. No further information was reported. Additional information was received from a manufacturer representative (rep) and the patient. The rep said the patient did not have any stimulation change following the fall. The patient just had tenderness around the battery site. The patient was advised to consult with her doctor. The patient reported that they met with a manufacturer representative (rep) who created two new programs for the patient to try. The patient said when the rep left, it was perfect, but soon after her vagina started vibrating at the top. The patient noticed it was like her vagina started jumping around and shooting over the front. The patient also noted it was the first time she experienced this. The patient said the issue happened on the 23rd or 24th. The rep put the device back on the other program a few days later. The patient reported they fell and slammed her back and the patient had vertigo. The patient said her legs have been ringing for the last two weeks. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a legal letter. It was reported that the patient sustained injuries and damages as a result of a defective stimulator. From the moment the stimulator was activated, the patient knew something was wrong. They felt as though they were being electrocuted. This feeling was not isolated to their back; they were being shocked in their left arm, buttocks, left leg, vaginal area, and across their chest. The shocking caused incredible pain and it was constant until they finally turned the device off in (b)(6) 2018. Even after the device was turned off, the patient continued to experience a lingering tingling sensation, later revealed to be neuropathy, in their extremities and legs. The stimulator was removed in early 2019, but the tingling and neuropathy caused the patient¿s legs to give out. The patient was examined by medical professionals and learned the fall had actually broken the patient¿s rib. It was noted that there was no evidence that the device had been damaged or that any other event had occurred that could have caused the stimulator to malfunction other than a defect.
 
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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 Key8032210
MDR Text Key126080094
Report Number3004209178-2018-24520
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 company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/19/2018
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: 11/02/2018 Patient Sequence Number: 1
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