MAUDE Adverse Event Report: RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; ANTERIOR & POSTERIOR LEAD

Model Number P01363-001

Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/27/2020

Event Type  malfunction  

Event Description

This patient started experiencing low impedance levels on posterior tip to ring.The patient got a red light, the site was able to clear codes (too many therapy retries) and got it going and about 10 minutes into the live test it happened again, the site continued to clear code again, the patient left the office charging.After charging, the patient's therapy started back up and she got red light.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: ANTERIOR & POSTERIOR LEAD
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul, mn
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 2800 patton road; saint paul, mn
• Manufacturer Contact: kristin wielenga ; 2800 patton road; saint paul, mn
• MDR Report Key: 10221541
• MDR Text Key: 200771357
• Report Number: 3005025697-2020-00002
• Device Sequence Number: 1
• Product Code: PIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P01363-001
• Device Catalogue Number: MAESTRO MODEL 2200P-47E, LEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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