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

Model Number 97714

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Chills (2191); Malaise (2359)

Event Date 03/28/2017

Event Type  malfunction  

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 patient with an implantable neurostimulator (ins) for spinal pain and complex regular pain syndrome type i (crpd).The patient reported that beginning this past weekend they started to notice an increase in stimulation/stimulation all of a sudden gets really strong when the patient changes position and is doing certain things.The patient is trying to walk a lot while healing from the implant surgery and when they were walking they started to feel the pulsing very hard.It made them really sick and gave them a bad headache.The patient did not have their patient programmer with them when it occurred.The patient did not know that a mobile program existed, but now they know about it.On (b)(6) 2017 the patient went into the mobile position and decreased stimulation and it was okay now and feels much better.The manufacture representative (rep) did not give the patient clear answers about the patient programmer features and whether they could set different positions.The patient spoke with their rep on (b)(6) 2017 who told them that there was an upright position.The patient was now able to change amplitude without having to wait in that position for 3 minutes.The patient noted that before they go back to work they want to figure out how to work the patient programmer better.The patient stated that their therapy helps with their pain and is definitely better.The patient has crpd in both of their legs, but it is worse in their right leg so their stimulation is higher in their right leg than in their left leg.They also noted that the therapy does not take care of their coldness but it helps with the nerve pain and they are happy with that.The patient has an appointment with their healthcare professional (hcp) on (b)(6) 2017.No further complications were reported/are anticipated.

Manufacturer Narrative

Corrected information: sex, date of birth.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6513368
• MDR Text Key: 73459296
• Report Number: 3004209178-2017-08839
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Date Device Manufactured: 02/09/2017
• 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 Age: 48 YR