MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Low impedance (2285); Impedance Problem (2950)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3777-60 ,serial#:(b)(4), implanted:(b)(6) 2013, product type: lead ; product id: 3777-60 serial#:(b)(4), implanted: (b)(6) 2009, product type: lead.Other relevant device(s) are: product id: 3777-60, serial/lot #:(b)(4), ubd: 27-jan-2016, udi#: (b)(4) ; product id: 3777-60, serial/lot #: (b)(4), ubd: 08-may-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins).Information was reported that the patient had a reduction in stimulation when they were previous well stimulated.An impedance connectivity check showed the 8-15 lead with no connectivity on any contact and a short throughout the whole lead.The 0-7 lead had contact 7 not connected.The rep tried adjusting the contacts working to supply stimulation, but ultimately it was decided to refer the patient to a surgeon for a complete replacement.The replacement is planned, but is not scheduled.

Manufacturer Narrative

Product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the cause of dysfunction was unknown.No date for replacement had been set.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, 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 Key: 10284647
• MDR Text Key: 199240383
• Report Number: 3004209178-2020-12336
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention