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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 07/07/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins) for spinal pain.Patient has a cranial peripheral nervous system (pns) lead placed horizontally above her right ear and a pns lead placed vertically on the right side of her neck.The lead in her neck is still implanted and without issue.On (b)(6) 2018, the patient called her hcp to report that her cranial lead protruded through her skin on (b)(6) 2018.Stating the concern for infection, the hcp decided not to remove the protruding lead, so he trimmed the lead at the protrusion site and sutured it closed.Patient reported no falls, trauma or injuries that would have contributed to the lead protruding.The patient shared that on saturday, (b)(6) 2018 she had just woken up, was sitting up in bed and simply looked down, felt a ¿pop¿ and felt the lead protruding through her skin above her ear.Because it was a saturday and because she is between jobs without health insurance, she waited until monday, (b)(6), to report the incident to her surgeon.With respect to the patient¿s programming, impedance test returned normal results on her pns neck lead (lead #2).The representative deleted lead #1 from her programming and reprogrammed lead #2, which proved to return half of her therapy.The hcp plans to remove and replace affected lead at a later date to be determined.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation: product id 977a290 lot# serial# (b)(4) implanted: 2016 (b)(6) explanted: 2018 (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the patient's lead was partially explanted on 2018-(b)(6).The remaining lead was pulled today (2018-(b)(6)) and replaced with a new one.No further information was reported.

Manufacturer Narrative

Continuation: product id 977a290 lot# serial# (b)(4) implanted: 2016 (b)(6) explanted: 2018 (b)(6) product type lead product id 977a275 lot# serial# (b)(4) implanted: 2016 (b)(6) explanted: product type lead.Device code does not apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Representative reported lead was discarded.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected information.If information is provided in the future, a supplemental report will be issued.

• 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: 7682863
• MDR Text Key: 113865855
• Report Number: 3004209178-2018-15634
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 07/01/2016
• 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
• Patient Age: 35 YR