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

Model Number 7427

Device Problems Therapy Delivered to Incorrect Body Area (1508); Unable to Obtain Readings (1516)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Date 08/01/2004

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for multiple back operations.It was reported that the patient could only feel stimulation in their left hip down to their knee area, but the target area was bilateral back and legs down to their toes.He only had adequate stim in the target area for about six months after implant, then he lost therapy benefit in the target area.The rep stated that the patient had stimulation on ¿for a while¿ because they haven¿t been feeling stim in their target area and there were no trauma/falls reported that could be related to this issue.The results of the impedance measurements showed all were 690 or 1395 ohms at default settings, 721, 909, 1221 ohms at 2.5v and ¿?¿ on 0/2 and 6/7 electrode pairs.On the day of the report, the implantable neurostimulator (ins) was at 2.6v (40-80% used) and the rep tried to program all sides of the lead in various ways,but the patient always felt stim in their left hip to knee area.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer¿s representative (rep) indicating that the causes of the stimulation not reaching the target area and the ¿?¿ impedance were undetermined.The rep indicated that they discussed the issues with the physician and they would discuss with the patient if it was worth replacing since the patient had not benefitted from the system.It was reported that the issues had not been resolved.No further complications were reported.

• 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: 7235768
• MDR Text Key: 98994092
• Report Number: 1030489-2018-00155
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

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: 05/28/2005
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/21/2018
• Date Device Manufactured: 12/05/2003
• 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 Age: 47 YR