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

Model Number 97714

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problems Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial (b)(4), implanted: (b)(6) 2017, product type: lead.The main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot (b)(4), ubd: 19-jan-2021, (b)(4); product id: 977a260, serial/lot (b)(4), ubd: 16-jan-2021, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) and consumer regarding a patient who was implanted with a neurostimulator (ins).Information was reported that the patient feels as though she can feel her lead wires.She also complained that her battery heated up during normal usage.The rep attempted to reprogram to reposition power from the lead.The rep also asked the office staff to a ct scan of the leaves and battery to rule out flipped battery and wires against the patient's skin.The impedances were normal.The issue was not resolved at the time of this report.No further complications were reported.No additional patient symptoms were reported.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7647571
• MDR Text Key: 113003054
• Report Number: 3004209178-2018-14596
• 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: Patient
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2018
• Date Device Manufactured: 02/03/2017
• 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 Age: 63 YR