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

Model Number 97714

Device Problems Labelling, Instructions for Use or Training Problem (1318); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 04/25/2016

Event Type  Injury  

Event Description

A patient reported they had experienced pain since implant and had consulted with their healthcare provider and manufacturer representatives multiple times for adjustments.The patient also reported that she was very uncomfortable with the placement of the implantable neurostimulator (ins), not only in the thoracic area, but the patient could not wear a bra or back brace and could not have any thing touch the ins implant area.The patient states she can't lay flat on her back due to the placement of the ins.The patient states also that the ins extends out, you can see it and touch it and it is very uncomfortable for the patient.The patient further reported they were provided with external equipment and a packet of information with no instructions and that they were under anesthesia when the instructions were provided.The patient was redirected to their healthcare provider.The indication for implant was spinal pain.

Event Description

Additional information was received from the healthcare provider indicating that the patients device will be explanted on (b)(6) 2016.It was reported that the patients stimulator gave them some coverage, but they have pain around their ribs and towards their breast area.Even when the stimulator is not on, the patient feels irritation.Re-programming was attempted with no success.The patient continued to have significant rib stimulation, intermittent abdominal pain, and some thoracic radicular pain.It was also noted that the patient had some numbness along with their rib discomfort on the right side.There was also some pinching at the battery site, and thoracic root irritation.It was mentioned that the patients implant subsequently required multi-level laminectomies to place the paddle, and it is likely that some of the patients pain is from the dissection of the surgery.The patient was not satisfied with their coverage from their stimulator.The patient has requested to have the device removed in hopes of alleviating their thoracic discomfort.

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 the patient.It was reported that the patient's ins was explanted in (b)(6) 2016 because "it was touching the dura." the patient mentioned that they had had complications since the device was implanted.The patient stated that it feels like "something is still in there." the patient reported that they haven't been able to wear a bra or lift their arms since the ins was removed and that there was a "bulge." no further complications are anticipated.

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: 6085953
• MDR Text Key: 59466399
• Report Number: 3004209178-2016-23420
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Date Device Manufactured: 02/16/2016
• 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: 59 YR