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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 97713
Device Problems Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331)
Event Date 07/18/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins). It was reported that the patient have not been able to recharge the ins in the last 2-3 days because the recharger (insr) screen kept displaying the "charge the insr", even though the desktop charger (dtc) was plugged into the insr. Patient stated that she noticed that the dtc connector pin was broken off. Patient reported the ins battery was depleted due to these issues, so her leg was "screaming at her" (this was understood as pain). Patient had to take naproxen to help with the pain. A replacement dtc was sent to the patient.

 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10332354
MDR Text Key200623463
Report Number3004209178-2020-12953
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2017
Device MODEL Number97713
Device Catalogue Number97713
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/06/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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