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

Model Number 97713

Device Problems High impedance (1291); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Electric Shock (2554)

Event Date 06/01/2018

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 manufacturing representative (rep) and consumer regarding a patient who was implanted with a neurostimulator (ins).Information was reported that the patient contacted their rep saying that she started to have a "surge" of energy and she had to turn the stimulation off.This surge was too strong.The rep is going to meet with the patient on (b)(6) to check her system.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).It was reported that the rep met with the patient on (b)(6).The cause of the surge was not determined.Rep checked impedances and #6 was over 10,000 but #6 electrode was not being used in programming.Rep reprogrammed the patient and was able to achieve better coverage for the lower back down the legs.Rep could not reproduce the "surge".Unknown if the surge has been resolved.Information was confirmed by patient.No patient symptoms or complications were reported in this event.

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 was received from the patient.The patient reported that her reason for calling was because she was having trouble with the neurostimulator (ins).The patient explained that the ins was sending bolts of shocks through her body and that these shocks were in places that the stimulation not normally goes.The patient further explained that the shocks ¿shoot from her back.¿ the patient reported that sometimes when she was sitting, she felt shocks ¿shoot through her¿ but noted she did experience the shocks when she changed to other positions.The patient reported that the shocks were ¿sporadic.¿ the patient didn't have any falls or traumas that could be related to the issue.The patient reported that she had kept the ins off because she was uncomfortable and ¿really having a lot of pain¿ due to the trouble she was having with the ins.No further complications were reported.

• 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: 7664646
• MDR Text Key: 113256103
• Report Number: 3004209178-2018-15090
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

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: 12/14/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/17/2015
• 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: 50 YR