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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Malposition of Device (2616); Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 07/24/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for lumbar radiculopathy and spinal pain.It was reported that initially after implant the therapy wasn't helping patient very much, it was hurting more than helping.It didn't do what they thought it would do at the time.Patient thinks inflammation could have been a factor.Patient began losing weight in (b)(6) 2017 (starting weight (b)(6) lbs) lowest weight (b)(6), current weight (b)(6) lbs.Patient gained a few lbs back when she quit smoking.Result from the weight loss is that ins does not protrude, but patient notices she can see ins more due to how many inches she lost.Patient reviewed through the weight loss she also addressed the inflammation and her therapy began working much better for her until recently.Patient noticed something she described as feeling like a short.In different positions she can feel stim (like straightening up her back) and not feel stim.Stim is not pulsating as strongly and she has to keep turning it up.Caller noted turning her favorite program up to 10.10 which she's never had that high before.Patient reviewed a progression that last night she didn't feel stim at all since the battery died and needed to be charged it had turned off, but patient charged ins and this morning went to turn stim on and cannot feel stim on her favorite program, but does feel stim on another program.Patient has been using her favorite program for 2 years).Patient reported no trauma/falls/emi/activity.The event dates were provided as following: (b)(6) 2014- therapy not helping/hurting more than helping, (b)(6) 2017 weight loss began, noticed ins sticks out 2019, probably a couple weeks ago, probably this month- loss of stim.Patient stated that she only sees hcp when she has a problem.She hasn't been to hcp in 2.5 years.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), product type: lead; product id: 977a260, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.It was reported that the patient's last ins burned up completely and she had to have leads and all changed over on (b)(6).Patient mentioned that the leads had burned up and she stated it almost felt like she had a short in her system which she noticed in april.Patient reported in september of this year, they figured out that 12 of her 16 leads were burned up.Patient stated they were going to replace the a battery, but they had figured out that both the leads and battery had burned up so she had to have everything replaced.Issue was resolved.No further complications were reported/anticipated.

• 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: 8602381
• MDR Text Key: 145113316
• Report Number: 3004209178-2019-09427
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Date Device Manufactured: 02/18/2014
• 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