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

Model Number 7427

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Impedance Problem (2950)

Patient Problems Failure of Implant (1924); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 01/01/2016

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 manufacturer representative regarding a patient who was implanted with a neurostimulator for failed back surgery syndrome.It was reported that the patient had the implantable neurostimulator implanted to address back and leg pain and the implantable neurostimulator therapy initially helped with back and leg pain.The leg pain subsided in 2004 when his hip was replaced, but the back pain got worse 2 years prior to the report (confirmed as 2016) and the patient had a spinal fusion at that time.The manufacturer rep resentative was attempting to reprogram the implantable neurostimulator to improve therapy for back pain on the day of the report, and reprogramming the implantable neurostimulator was not initially successful to provide improved therapy for back pain.After impedance testing at 1.5 volts in an attempt to reprogram the patient with therapeutic stimulation with the lead placed at 8 and 9, with electrodes 4, 5, 6 and 7 greater than 4000 ohms.Using electrode 6 and 7 with the voltage up to 10.5 volts, the patient felt nothing.Using electrode 2 and 3 at 1 volt, the patient felt stimulation but inthe left rib which was not the therapeutic area needed.The clinician programmer showed question marks for electrodes 0, 3, 5, and, 7 during the first impedance test.The manufacturer representative was inquiring whether or not the ¿whole lead was bad.¿ the manufacturer representative increased the intensity to 1.8 volts during the impedance testing and the patient ¿got a little jolt¿ with electrodes 4, 5, 6, and 7 all greater than 4000 ohms and electrode pair 4 and 7 with impedances greater than 4000 ohms.The question marks resolve, but all electrodes were still measuring greater than 4000 ohms demonstrating that side of the lead has consistently bad impedances.It was recommended that the manufacturer representative try to program therapy on electrodes 0-4, if possible.If this did not resolve the issue, the patient would be referred to a surgeon for a lead revision.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that reprogramming was performed, but it was unknown if it helped the therapy.No further complications are anticipated.

Manufacturer Narrative

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

• Brand Name: SYNERGY
• 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: 7714018
• MDR Text Key: 115256351
• Report Number: 1030489-2018-01047
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2004
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 07/26/2002
• 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: 51 YR