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

Model Number 97714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

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

Event Date 08/22/2016

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that two weeks prior to the report, the patient suddenly felt that the stimulation wasn't working.The week prior to the report, the patient started making adjustments using his patient programmer, and he couldn't remember what he did and was having issues with the patient programmer at the time of the report.It was reviewed how to sync, and the patient was able to connect to the implantable neurostimulator right away.The patient has adaptive stimulation programmed for both group a and b.The patient was feeling stimulation in his lower back and top of the leg muscle as he usually does.Since implant, they have not been able to program the stimulation so that he doesn't feel it in the top of his leg muscle.The patient was going to finish up the process of adjust ing the settings for adaptive stimulation and work with the two programs.If needed, he was going to contact the health care provider office to schedule reprogramming session to tweak the adaptive stimulation settings; however, the patient didn't intend to follow up with any health care provider.

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.The patient reported that they were having excessive back pain since (b)(6) 2017.The patient checked the stimulation with the patient programmer and it showed that it was turned off.The patient turned the stimulation back on and the patient was able to feel stimulation.The patient noted that they "never used the patient programmer" and they did not know how the stimulation could have gotten turned off.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: 6393953
• MDR Text Key: 69563524
• Report Number: 3004209178-2017-05374
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2017

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: 06/28/2017
• 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: 03/06/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided; 05/18/2017
• Supplement Dates FDA Received: 05/22/2017; 10/02/2017
• Date Device Manufactured: 08/12/2016
• 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 Age: 65 YR