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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 Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418)
Event Date 05/18/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 977a260, lot# (b)(4), serial# (b)(4), implanted: (b)(6) 2015, product type: lead, product id: 977a260, lot# (b)(4), serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 08-jan-2019, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 12-aug-2018, udi#: (b)(4), (b)(4). 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 an implantable neurostimulator (ins) it was reported that around (b)(6) 2020, the patient started noticing therapy issues. It was explained that the leads had fell down from their thoracic spine area and curled up in their lumbar area. The patient had discussed this with their physician on two occasions. The physician assistant was able to feel that the leads had fallen. X-rays were done of their back. Then, on (b)(6) 2020, the patient started noticing "3 different pains", which was explained to mean that they could feel the pain around their mid-to-upper incision where the lead was and it would be felt to their toes. This pain was so intense for the patient that they felt like they would black out or they had passed out and fell. This had occurred 3 different times. The patient was redirected to see their doctor regarding their symptoms and the leads migrating.

 
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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 Key10426990
MDR Text Key207165507
Report Number3004209178-2020-14371
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 08/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2015
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 Received08/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/17/2015
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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