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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 97712
Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913)
Patient Problems Emotional Changes (1831); Fall (1848); Muscle Weakness (1967); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Complaint, Ill-Defined (2331); Injury (2348); Peroneal Nerve Palsy (2362); Numbness (2415); Ambulation Difficulties (2544)
Event Date 12/31/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 97754, serial# (b)(4), product type: recharger. 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
A consumer reported that they got a new device implanted on the wednesday before the report and it stopped working on the saturday prior to the report. They were not able to charge the implantable neurostimulator (ins) and were seeing an icon on their recharger telling them to charge the recharger battery. The patient had experienced a loss of stimulation. The patient was instructed not to charge the ins until their follow-up appointment on (b)(6) 2017 and was told the battery would last two weeks but it didn¿t last more than a couple of days. The patient noted that they had emotional problems, were hurting, and in pain and didn¿t want to troubleshoot over the phone. Due to the device not working the patient fell and hurt their ankle on (b)(6) 2017. The patient had drop foot because of the nerves in their lower back and had to use a brace. They also suffered from chronic pain and would lose their balance. It was also noted that the patient didn¿t have full control from their waist to their arms and didn¿t have the strength to pick things up if they dropped them. They would have to lay their arms across their legs to reach and try to pick things up.
 
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 healthcare provider (hcp) regarding an implantable neurostimulator (ins) for the treatment of spinal pain and lumbar radiculopathy. It was reported patient has some past medical issues that are unrelated to the device and therapy. The patient stated that they have had back and leg pain since 2003. The patient states that most of the pain begins in their low back, will radiate to their buttocks bilaterally down to their legs with the pain in the right side greater than the left along the posterolateral aspect of the right leg along the l5-s1 distribution. Currently the patient describes their pain as sharp, spasm, tingling, numbness, stabbing, and tiring pain; worsens with activity such as exercise, walking, standing, lifting, bending, lying, sitting, rest, heat, and cold. The patient stated that the pain improves with nothing but pain and neuromodulation. Currently the patient describes their pain as constant, worse in the morning mid-day and evenings. The patient rates their pain at 9/10 right now, the worst 10/10 and average daily pain is 9/10. The patient was referred as they had gotten a scs trial and they did very well. The patient stated that they had anywhere from 60-75% relief with the trial and wanted to continue with the implantation of the device. When asked about the pain association they complained about numbness and tingling in their right leg. The patient has what they describe as drop foot on the right leg and difficulty walking but this is associated with the pain. The patient believes this happened after the surgery, which occurred in 2006, and was before the patient was implanted.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6279471
MDR Text Key100822127
Report Number3004209178-2017-01788
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109506
UDI-Public00643169109506
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 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
Device Model Number97712
Device Catalogue Number97712
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 Received02/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/23/2016
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: 01/26/2017 Patient Sequence Number: 1
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