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

Model Number 97713

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Malaise (2359); Electric Shock (2554)

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 healthcare professional via manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that patient was experiencing zapping and shocking through whole body when stimulation was off.Patient normally felt stim in their waist and legs.Patient was feeling shocking under arms, in joints and through the whole body.The continuous shocking started 5 days prior to the date of report.There were a couple instances prior to that as well.The first was 2-3 months prior to the date of report.That's when patient called 911 because they thought they were having a heart attack.Patient claimed that they changed their medication couple of days prior to the date of report.Patient's stim was off.The programmer diary showed that over the past five days, the ins was off the majority of the time.The stim was on 5-20 % each day.Patient confirmed that they had stim off but had turned it on when they were not feeling well.A program was turned on and the patient felt flutter or zap in knee at 2.5 v and the electrodes used were +3 -4 +5.Other programs were tried which resulted in fluttering in the crotch area and stim in stomach.Impedance measurements were taken.At 0.7 v the impedances were between 699-971 ohms except 12 was at 2091 ohms.

Manufacturer Narrative

Upon further review of the information, device code (b)(4) is not applicable.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.

Manufacturer Narrative

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6277666
• MDR Text Key: 65773430
• Report Number: 3004209178-2017-01726
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• Date Device Manufactured: 01/07/2016
• 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: 50 YR