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); Unable to Obtain Readings (1516); Self-Activation or Keying (1557); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the rep ran an impedance check and saw 'xxx.' the rep re-ran the check and the xxxs cleared up.It was also reported that the patient feels intermittent jolting when they sleep at night, even though they don't move.The intensity was increasing on its own.It was noted that adaptive stimulation was enabled.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id 977a260, implanted: (b)(6) 2016, product type lead; product id 977a260, implanted: (b)(6) 2016, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the cause of the patient's intermittent jolting was due to their leads migrating up 2 vertebral spaces.The patient is being scheduled for a revision of their leads.No further information was reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the reported that the lead revision was scheduled for (b)(6) 2018.No further complications 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
• MDR Report Key: 7742562
• MDR Text Key: 116065526
• Report Number: 3004209178-2018-17237
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR