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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 Use of Device Problem (1670); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Unspecified Infection (1930); Distress (2329); Discomfort (2330); Malaise (2359); Impaired Healing (2378)
Event Date 09/30/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported that they were getting poor coupling when recharging. Recharging best practices were reviewed at the time of the report, and the patient then noted getting 6-8 coupling bars. The patient mentioned that they were recently implanted on (b)(6) 2016-09-15, and got an infection at their implant site. The patient stated that they noticed the infection at the end of september, and was given ¿some giant pills¿ that make them sick. Due to the patient¿s infection, they have been in 2 different hospitals. At the time of the report, it was noted that the patient was confused on recharging. They stated they are frustrated and upset because they can¿t get any bars to show up. The patient mentioned they are uncomfortable and need to lie down. It was reported that a manufacturing representative would meet with the patient to show them on how to use recharging equipment. The patient stated they cannot find the correct place for the recharger, and it is driving them crazy. They noted they have been trying to charge since the sunday prior to the report, and is now low on charge. It was reported that the patient¿s recharger does not show that the ins is on; it¿s blank. The patient mentioned that they are charging over their underpants, because they have not healed very much since implant. The patient was implanted for non-malignant pain.
 
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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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6074087
MDR Text Key101192695
Report Number3004209178-2016-23084
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
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 Received10/10/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/09/2016
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: 11/02/2016 Patient Sequence Number: 1
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