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

Catalog Number P01362-001 & P01363-001

Device Problem High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

The device was implanted on (b)(6) 2018.Out of range anterior tip to posterior tip lead impedance, therapy was not being delivered due to an impedance of 1687 ohms.

Event Description

The device was implanted on (b)(6) 2018.Out of range anterior tip to posterior tip lead impedance, therapy was not being delivered due to an impedance of 1687 ohms.

• Brand Name: MAESTRO RECHAREABLE SYSTEM
• Type of Device: ANTERIOR & POSTERIOR LEAD
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 8984049
• MDR Text Key: 195275447
• Report Number: 3005025697-2019-00006
• Device Sequence Number: 1
• Product Code: PIM
• Combination Product (y/n): N
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: P01362-001 & P01363-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1