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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 01/01/2017

Event Type  Injury  

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

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient had a return of symptoms.The patient stated that they have been implanted not even for a full year the device still doesn't help with knee pain.The patient had settings checked by a manufacturer's representative (rep) multiple times and hasn't resolved.The patient was unsure what to do so they just kept the device charged.The patient met with their healthcare provider (hcp) and planned ins removal.The patient reported previously stated information.The patient stated that prior to the unrelated surgery both of their legs were red and very swollen.The patient met with their hcps and had an mri and medications to aide in the nerve pain.The doctor thought that these issues were stemming from the ins.The leads were checked.The patient reported spine/back pain, and knots/lumps on the bottom.The patient stated that they had a second unrelated surgery and everything went downhill.The patient was in the hospital for a while and got out last tuesday.The patient was given an infusion for pain as they were in extreme pain, but the patient had a bad reaction to that.The patient was not able to receive an epidural for pain.The patient also stated that they do not think the lumps on the bottoms are related to the ins/therapy.The patient noticed something at the surgical site on the spine that was moving.The patient also noticed that the ins was raised above the skin and can be seen through clothing and there was bruising at the ins site.The ins was moving, but had not protruded through the skin.The patient met with the healthcare provider (hcp) to check for mersa to cover bases for pre-admission to surgery, the doctor does not want to risk the ins eroding through the skin, and there is a plan in place in case that occurs.The patient has plans to get ins removed within 2 weeks.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6439911
• MDR Text Key: 71051943
• Report Number: 3004209178-2017-06512
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Date Device Manufactured: 10/22/2013
• 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: 59 YR