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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); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient had poor/no telemetry with recharging the ins and needed an mri (not related to the device/therapy). It was noted the patient had turned stimulation off around 6-8 months (or longer) prior to the report and had not charged the ins nor felt stimulation during that same time. They had contacted the manufacturer to see what they had to do to get the ins ¿jump started¿ so they can put it in the mri mode. They mentioned that their doctor told them that it was ok to turn it off and they could jump start it as needed. It was reviewed with the patient that even with the device being off, it was important to continue to charge it. The patient also reported they started to have more pain with the ins turned off. They also had new pain which their doctor told them it was sciatic pain but the patient was not sure. The patient stated they also had shoulder and arm pain and that their fingers get ¿tingly¿. They mentioned their fingers and arms go numb as do their legs. The patient did not have any reprogramming. The patient was redirected to follow up with their healthcare professional (hcp) to jump start the device. Additional information was received from a manufacturer representative (rep) on july 30, 2018. They confirmed the ins had gone into overdischarge because the stimulation had not helped with their chronic pain. The ins was explanted as a result, which occurred on (b)(6) 2018. The ins and leads were discarded by the doctor so they could not be returned for analysis. The issue was resolved; no further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7745017
MDR Text Key115892130
Report Number3004209178-2018-17319
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
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2017
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2016
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: 08/02/2018 Patient Sequence Number: 1
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