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

Model Number 97712

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 07/12/2016

Event Type  Injury  

Event Description

Information was received from a healthcare professional of a clinical study regarding a patient with an implantable neurostimulator (ins).A clinical diagnosis of pocket/incisional pain and therapy inadequate to control the patient's pain was reported.A device diagnosis was not applicable.The patient reported the "scs was 'slipping out'".On (b)(6) 2016, the patient reported having worsening pain in the lumbar and lower extremity.At the office visit on (b)(6) 2016, the patient felt the stimulator wasn't providing adequate relief and some minor irritation at the scs device sites (generator and lead anchor locations).The medical doctor's assessment included the following: "patient with scs implant, mild irritation at left buttock incision site and midline lumbar spine area".The medical doctor's notes indicated the device was interrogated, the programming was adjusted, and provided better pain coverage and stimulation.The event resolved without sequelae on (b)(6) 2016.The event was possibly related to the device or therapy and was not related to the implant procedure.No further complications were reported as a result of the event.

Manufacturer Narrative

The type of reportable event has been updated to serious injury.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 from the healthcare professional of the clinical study reported the event was not related to the device or therapy and possibly related to the implant procedure.A battery revision was scheduled for (b)(6) 2017 to change the pocket placement.The event was ongoing.

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

The patient's relevant medical history includes back pain with leg pain (injury/fracture) and a laminectomy in (b)(6) 2009 (l3, l4, l5).

Event Description

Additional information was received from the healthcare professional of the clinical study.Regarding the patient's report at follow-up that the pain control was inadequate, there was no further information regarding the root cause.The event resolved without sequelae via reprogramming.Regarding the device discomfort and the patient's reported feeling "that the scs is 'slipping out'", no further information or clarification was provided regarding this comment.It was unknown whether the device pocket issue was related to the pain control issue, but it appeared unlikely.The patient had a pocket revision to reposition the ins and change the pocket placement as planned on (b)(6) 2017.

Event Description

The patient reported on (b)(6) 2016 that the worse pain was located in the lower back and radiated to the legs.The patient felt this pain constant and rates it 10/10.On (b)(6) 2016, the patient reported the pain was located in the lower back and legs and felt this pain constant.The pain was rated 7/10.On (b)(6) 2016, the patient's pain level was an 8.The pain was at the back of the legs.An x-ray of the thoracic spine on (b)(6) 2016 revealed the lead tip was at t8.A ct of the thoracic spine was performed on (b)(6) 2016.The patient reported the ins was in an uncomfortable area.The patient reported no change in back and leg pain on (b)(6) 2016.The patient reported the scar from the ins was painful and sensitive.Reprogramming was attempted but there was no change in symptoms.A pocket revision to reposition the ins was performed on (b)(6) 2017.The event resolved without sequelae.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional of the clinical study.The device diagnosis was ins migration.It was also reported that reprogramming was performed on (b)(6) 2016.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6454146
• MDR Text Key: 71543966
• Report Number: 3004209178-2017-06898
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• Date Device Manufactured: 11/22/2015
• 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
• Patient Age: 40 YR
• Patient Weight: 73