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 High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2017

Event Type  Injury  

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for post laminectomy pain.It was reported that impedance issues were noted with the patient¿s ins, and the patient was due for an ins replacement.Impedance measurements were ran at 3.0v and electrode pairs c<(>&<)>1, c <(>&<)>2, 0<(>&<)>1, 0<(>&<)>2, 1<(>&<)>2, 1<(>&<)>3, and 2<(>&<)>3 were all >4,000 ohms.C<(>&<)>0 and 0<(>&<)>3 were 874 ohms, while the measurement for c<(>&<)>3 gave an invalid ¿???¿ value.No symptoms were reported.Additional information from the rep reported that the cause of the high impedance was not determined.It was noted that the troubleshooting performed was that they tried increasing the voltage.A surgery was scheduled to replace the ins to resolve the issue.Due to the patient¿s age and adequate coverage, the current paddle lead was going to be left in place.

Event Description

Additional information was received from a rep reporting that tech services(tss) had spoke (b)(6) on friday, (b)(6) about this patient.Tss had reviewed basic replacement considerations.(b)(6) sent an x-ray impage to tss.No further patient complications have been reported as a result of this event.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6344483
• MDR Text Key: 67803745
• Report Number: 1030489-2017-00343
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2017

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: 01/28/2005
• 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: 02/09/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided; 03/17/2017
• Supplement Dates FDA Received: 04/10/2017; 09/29/2017
• Date Device Manufactured: 08/12/2003
• 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
• Patient Age: 80 YR