MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Low Battery (2584); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 01/09/2018

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 patient with an implantable neurostimulator (ins) for other chronic/intractable pain (trunk/limbs).The patient stated that their implant is turning on by itself and giving them ¿all kinds of fits¿ including sending terrific shocks all the way down both of their legs.It is not responding to the remote.The patient stated that they have not used their implant in 20 years which they then clarified by stating that they used it for about a year then turned it off because they no longer needed it.During the report the patient synced with the patient programmer but it only showed the patient programmer battery light green.The patient was sent a list of healthcare professionals (hcp) to follow up with.No further complications were reported/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 on (b)(6) 2018.On (b)(6) 2018 they went to the hospital for an unrelated condition.At 2:30pm their device began shocking both of their legs from the waist to their toes.The patient has a pacemaker/defibrillator and initially they thought it was going off.However, as they screamed the nurses and two doctors came running.Shortly, they concluded that it was their stimulator.This went on for over an hour.It was very intense and painful.Finally, the device stopped (battery went dead).They had their daughter bring the remote but it did not help to turn it off.They have not been using the stimulator for over 10 years.The implant spontaneously turned itself on and would not respond to the remote.The cause remains unknown.After leaving the hospital they contacted the manufacturer.The tech ran a test and found that the battery had now completely run out of energy.They were also sent a list of doctor¿s that take all of the device.However, they cannot afford to pay them to remove it as they do not need it to work.It does not work anymore.No further complications were reported/are anticipated.

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7235280
• MDR Text Key: 98991526
• Report Number: 1030489-2018-00153
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 03/01/2018

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: 03/14/2002
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/01/2018
• Date Device Manufactured: 09/27/2000
• 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: 79 YR
• Patient Weight: 86