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); Unable to Obtain Readings (1516); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problem Electric Shock (2554)

Event Type  Injury  

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 manufacturing representative (rep) regarding a patient implanted for other chronic/interact pain (trunk/limbs).The patient reported feeling a shocking sensation when passing through security gates, regardless if the implantable neurostimulator (ins) was on or off.The patient noted that there is a specific store where the shocking seemed more prevalent.It was mentioned that the patient was told by their physician that their ins had completely depleted approximately 10 years ago.Now the patient is seeking to restart stimulation therapy again.The rep mentioned that the battery status shows end of life (eol), but they were able to run a couple electrode impedance tests.They stated that the first test at default settings resulted in all "???" except contacts 0c, 12, 13, and 23.The rep ran another test, and then the ins showed a power on reset (por) error.They increased the settings to 3v and 300usec and was able to get reading for all contacts, which showed there were no impedances out of range.The rep stated that an x-ray of the lead looked good.It was also noted that an ins replacement will likely occur sometime in the future.No further complications were reported.

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

Additional information was received from the manufacturing representative reporting that the patient had not used their device for 10 years.The patient¿s weight was unknown and the cause of the por error was not determined.It was reported that this information was confirmed with the physician.The rep also called in requesting information about components to use for the replacement.No further complications were reported/anticipated.

Event Description

Additional information was received reporting that patient's ins was replaced (had a normal ins replacement) and the replacement serial number was provided.It was also reported that the device status was inactive and device would not be returned.It was reported that the most appropriate person to contact for additional information was the patient's doctor.No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: 6678430
• MDR Text Key: 78809566
• Report Number: 1030489-2017-01647
• 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,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2003
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Date Device Manufactured: 11/19/2001
• 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 Outcome(s): Required Intervention