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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 97702
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Sleep Dysfunction (2517)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017,product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for spinal pain. It was reported that the patient had a recent thoracic x-ray done due to an increase in pain to their right leg. It was noted that the implantable neurostimulator (ins) was placed for left leg pain in 2017. After reviewing the x-rays, it appeared that one lead (0-7) had migrated to the ins. The patient denied any falls or trauma. The rep interrogated the ins, impedances were within normal limits. Both leads were programmed, the 0-7 lead provided stimulation over the ins, and the 8-15 lead provided bilateral equal stimulation according to the patient. In the end, extensive reprogramming was one with the patient and the patient was able to report good coverage. There were no further complications reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. No new information.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. The patient reported that one of their leads fell to the bottom of their back and it is causing pain and they can't sleep. They stated that when the ¿wire¿ fell down and it ¿through them into something¿ and they ¿blacked out. ¿ they mentioned that if they cough or sneeze, they feel like their whole insides are coming out. The patient stated that they saw their healthcare provider (hcp) and was told they would have to wait a month before anything would be done about the issue. The patient mentioned that they wanted to have the device removed because it never worked. The patient was sent physician listings and was to follow-up with their healthcare provider.
 
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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 Key8567654
MDR Text Key143995047
Report Number3004209178-2019-08629
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2017
Device Model Number97702
Device Catalogue Number97702
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 Received01/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/17/2016
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: 04/30/2019 Patient Sequence Number: 1
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