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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2019 crts 3883714 (hcp): information was received from a healthcare provider (hcp) regarding a patient's implantable neurosti mulator (ins) for spinal pain in (b)(6) 2019. It was reported that the patient's external equipment was stolen and the ins didn't work. The hcp wasn't able to clarify what was meant by "doesn't work" but they assumed it had been a while since the patient charged the ins. No symptoms or further complications reported. Additional information was received from the patient in august 2020 reiterating that they had lost all of their equipment three years ago and their ins stopped working all together six months after having it implanted. They stated that now they needed their equipment so they could charge the ins for a procedure they were having on their shoulder. The event occurred in 2017. On june 15, 2021, additional information from the patient indicated that they need to meet with someone to get the ins "woken up. " they stated that it has been dormant for 4 years. On (b)(6) 2021, the patient called back requesting information on how to get their battery "jump started". Pt mentioned on the call that they just got replacement external equipment for their device. Pt said that just about a month ago they tried to charge their implant and they were unsuccessful. Pt s aid that they have no managing hcp at this time. Then, on (b)(6) 2021, the manufacturer representative (rep) was made aware that the patient hadn't charged the ins for a "couple years", so it had gone dead. As a result of it going dead, the ins was replaced.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12454442
MDR Text Key271692655
Report Number3004209178-2021-13671
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 Other Health Care Professional
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/08/2017
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: 09/10/2021 Patient Sequence Number: 1
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