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

Model Number 97702

Device Problems Intermittent Continuity (1121); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 10/16/2014

Event Type  malfunction  

Manufacturer Narrative

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 the treatment of non-malignant pain.It was reported that the patient couldn¿t get their device to stop the pain and they were really hurting.The patient stated that they could only sit in a recliner.The patient reported that when they lean back, ¿the power shoots up¿ and they have to get out of the recliner due to the ¿vibrating.¿ the patient was walked through switching to group a.The patient only had one program on group a and they set the stimulation to 6.0 v, but they were still having pain.The patient intended to follow up with their hcp if they did not receive pain relief.No further complications are anticipated.

Manufacturer Narrative

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 ins doesn¿t do any good.The patient wanted to know if she can shut the ins off in the meantime.The patient explained the ins was not doing any good because the pain is in a completely different spot.The patient said the pain got really bad in about the last 3 months.It was reviewed that the patient needed to coordinate with the healthcare provider (hcp) to turn the ins due to the patient losing their programmer.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It wasreported that a manufacturer representative tried to work with the ins to resolve the power increasing when leaning back, but it made no difference.The cause of the issue was unknown and the issue was unresolved at the time of the report.No further complications are anticipated.

Manufacturer Narrative

The patient clarified that the issue of the stimulation going full blast when leaning back started when they were implanted on (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient.It was reported that their stimulation went "full blast" when they sat and leaned back.They needed to do this more because of a leg problem (which was unrelated to their device/therapy) and every time they leaned back the stimulation was too strong.No further complications reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received from the patient reported that recently they met with a manufacturer representative and they helped adjust their stimulation, because it was not in the right spot.The patient stated that since then they had lost their patient programmer and they needed to turn the ins off because it was bothering them, because it was still not in the right spot.It was reported that the event occurred about a week prior to (b)(6) 2018.It was further reported on (b)(6) 2018 that the patient was having a hard time moving around.The patient stated that they were ¿kind of crippled up.¿ no further complications were reported or anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7664005
• MDR Text Key: 113253522
• Report Number: 3004209178-2018-15054
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/11/2013
• 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 Age: 75 YR