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

Model Number 97714

Device Problems Labelling, Instructions for Use or Training Problem (1318); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type lead.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain.The consumer reported that they were not getting relief from the device and the stimulation was felt in the wrong location.Specifically, the stim was anterior and her spot (where stim is intended to be felt) was posterior.The patient also reported that the stim was tightening up her abdominal muscle and the stim sensation was not near her pain.It was noted that the patient was meeting with a manufacturer representative (rep) on the day of the report and she was not given any type of instruction on how to use the patient programmer (pp); the manual was not easy to follow.The patient was trained under anesthesia and can only remember the manufacturer representative telling her to read the manuals.Additional information was received from a consumer regarding the patient on (b)(6) 2017 which reported that the patient had a lead revision on (b)(6) 2016 because therapy wasn¿t in the correct area since implant.During the surgery, the health care provider tried to pull the lead out a little.The patient was woken up to test the lead, but it wasn¿t working, so the entire lead was replaced.After the revision, the patient now has two leads both on the left side epidural space of the spine.

Manufacturer Narrative

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

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6308842
• MDR Text Key: 66761608
• Report Number: 3004209178-2017-02733
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: 02/03/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 08/16/2016
• 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
• Patient Age: 46 YR