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

Model Number 7427

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Scar Tissue (2060); Sepsis (2067)

Event Date 02/27/2001

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3986ilc lot# n25129 serial# implanted: (b)(6) 2001 explanted: (b)(6) 2007 product type lead product id 3986ilc lot# n25129 serial# implanted: (b)(6) 2001 explanted: (b)(6) 2007 product type lead.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 consumer regarding a patient implanted with a neurostimulator (ins) for rsd/causalgia-complex regional pain syndrome.It was reported by the patient that their ins was explanted due to developing sepsis.Patient had a nurse coming 2 to 3 times a day to re-pack and also administer antibiotics directly into the heart through a central line.Patient received this treatment for 3 months after the explant.Patient also received radiation medication and was checked while she was placed behind the walls.Patient also requested information for mri compatibility as 2 inches of the lead wire was left in c1, c2 and c3 because it was safer to leave it than to dig it out of the scar tissue.

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.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6247373
• MDR Text Key: 64674058
• Report Number: 1030489-2017-00083
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2002
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Date Device Manufactured: 08/26/2000
• 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): Life Threatening; Required Intervention
• Patient Age: 39 YR