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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 97702
Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Unintended Collision (1429)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 27-jan-2019, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 04-feb-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient fell and was unsure of date possible 2 months ago. The stimulator stopped working after fall.  connectivity check was performed and 8-15 leads were not connected. An explant was performed, 2 leads were removed and 2 leads were placed. The issue was resolved at the time of report. No symptoms were reported.

 
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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 Key10786612
MDR Text Key214641130
Report Number3004209178-2020-19316
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 11/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2016
Device MODEL Number97702
Device Catalogue Number97702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/11/2015
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: 11/04/2020 Patient Sequence Number: 1
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