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

Model Number 97714

Device Problems Electromagnetic Interference (1194); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Complaint, Ill-Defined (2331)

Event Date 02/23/2017

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The patient reported that stimulation was down the leg where it was mainly being in the back.The patient reported that when she coughed she had some across her midsection.The patient reported that she had an mri on (b)(6) 2017 on the lower back.The patient reported that she had previous problems on the left side of the back but would go down right side so stimulation was to help with both sides.The patient reported that she had never had stimulation in leg and that this started after the mri.The patient also reported that she kept feeling vibration in the leg.The patient reported that she thought it was her phone but it wasn¿t.The patient reported that she never had the ever before.The patient reported that it was still working on back but now in the leg too.The patient reported that she got new phones before the mri and not working properly.The patient reported that the stimulation was more and more increased daily.The patient reported that on the day of the report she could feel it in both legs while talking on the phone where on the night prior to the report was only in one leg.No further complications anticipated.

Event Description

Additional information was received from the patient.It was reported that an appointment was set-up, the program was changed, and the new stimulation in the legs was resolved.

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: 6450159
• MDR Text Key: 71419170
• Report Number: 3004209178-2017-06780
• 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: 06/14/2017

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: 03/28/2016
• 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: 03/09/2017
• Initial Date FDA Received: 03/31/2017
• Supplement Dates Manufacturer Received: Not provided; 05/30/2017
• Supplement Dates FDA Received: 06/14/2017; 10/02/2017
• Date Device Manufactured: 05/12/2015
• 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: 58 YR