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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 Problem Disconnection (1171)
Patient Problem Pain (1994)
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977c165, 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

On (b)(6) 2020, the patient reported that their wires are like ¿theft¿ and there is a big bump. They noted that they are looking for a physician. Physician listings were sent to the patient. The patient was redirected to follow-up with their healthcare provider. On 2020-july-20, additional information was received from the patient reporting that they had ¿two wires that had fallen off¿. They clarified this by saying that the leads were disconnected since two years ago. The patient stated that they had never had this much pain in their life. They stated that the pain was down their leg and into their foot and they could not stand on the left foot since a year ago. They stated that they wished they would have never gotten the pain stim device implanted and they did not have a current managing healthcare provider (hcp).

 
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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 Key10305699
MDR Text Key199831021
Report Number3004209178-2020-12574
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,Followup
Report Date 08/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
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 Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/12/2016
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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