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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

Information was received from a consumer via a manufacturer¿s representative regarding a patient with an implanted neurostimulator ( ins) for non-malignant pain.It was reported the patient was not getting stimulation in the left lead electrodes 0-7 (start of event was not known).Impedance check was performed and these high impedance results were noted: electrodes 0 and 2, 0 and 3, 0 and 4, 0 and 5 were all greater than 10,000 ohms when tested at 0.70 volts.Using electrode 1 reference high impedances were found when tested with #2-7 and #15 - all greater than 10,000 ohms.The following combinations measured within normal limits: 1 and 8 was 932 ohms, 1 and 9 was 922 ohms, 1 and 10 was 944 ohms, 1 and 11 was 980 ohms, 1 and 12 was 842 ohms, 1 and 13 was 788 ohms, 1 and 14 was 905 ohms.Using electrode 2 reference high impedances of greater than 10,000 ohms were found on electrodes 0 through 15 when tested at 0.70 volts.An x-ray was ordered and results were expected (b)(6) 2017; follow up will be conducted to learn next steps.It was also reported that impedances were normal during the implant procedure.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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) regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the rep was informed on (b)(6) 2017 that the patient was having issues with their stimulator.The patient stated that they didn't fall.The patient's healthcare provider (hcp) ordered x-ray and it showed that both leads were out from their initial placement.At this point hcp gave the patient an option to revise the leads and they are waiting on the patient.The left lead appears to be completely out based on the x-ray.

Event Description

Additional information was received from a consumer.It was reported that the patient the cause of the leads moving is unknown.The patient stated that nothing changed in their activity caused them to move.The patient stated that the healthcare provider (hcp) is going back into their back to place the leads again.This time they are going to place extra stuff will be placed in order to hold them in place better.The patient stated that the surgery is scheduled for (b)(6) 2017.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6281877
• MDR Text Key: 65903223
• Report Number: 3004209178-2017-01861
• Device Sequence Number: 1
• Product Code: GZB
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2017
• Date Device Manufactured: 10/03/2016
• 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