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 Electromagnetic Interference (1194); Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Therapeutic Effects, Unexpected (2099); Malaise (2359)

Event Date 10/23/2017

Event Type  malfunction  

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).The rep reported that the patient felt stimulation come back on today after 15-20 years of no stimulation.The rep reported that the patient believed that her ins had reached end of service (eos) 15-20 years ago but the rep was able to communicate with the ins on the day of the report.The rep reported that the patient had a ct scan on (b)(6) 2017 and the rep reported that the patient felt stimulation back on, on the day of the report.The rep reported that he turned the ins off and to 0.0v but the patient still felt stimulation.The rep confirmed with the clinician programmer that the reed switch was on.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative reported that it was unknown what caused the patient to feel stimulation.It was noted that they switched the magnet switch to the off position and reviewed that there may be some residual stimulation for 24 hours.The consumer mentioned the patient had an injection several days prior and had been sick ever since.

• 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: 6977281
• MDR Text Key: 90989049
• Report Number: 1030489-2017-02248
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

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: 10/14/1999
• 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: 10/23/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 10/31/2017
• Date Device Manufactured: 04/24/1998
• 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: 77 YR