MAUDE Adverse Event Report: ENTEROMEDICS, INC. MAESTRO RECHARGEABLE SYSTEM; POSTERIOR LEAD

Model Number 2200P-47E

Device Problems Electrical /Electronic Property Problem (1198); Fracture (1260); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591)

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

Event Date 11/23/2015

Event Type  malfunction  

Event Description

Subject participating in the recharge clinical trial ((b)(4)) experienced low impedance of posterior lead.Subject reported red light on external mobile charger during a clinic visit on (b)(6), 2015.Interrogation of the device indicated error codes including low rnr and posterior tip to ring short.Error codes were cleared, and therapy was delivered until (b)(6), 2015.The subject was unable to charge with the mobile charger, so the mobile charger was replaced; temporarily resolving the low rnr battery issue.The importance of regular charging was emphasized to the subject.On (b)(6), 2015, posterior tip to ring shorts were reported.Review of log data indicate shorts on (b)(6), 2015.On september 29, 2015, it was determined the low impedance state would persist and prevent therapy delivery, and the need for surgical revision was initially recommended.Therefore, this event was then determined, on (b)(6), 2015, to be a reportable event.A follow-up report will be filed after completion of the revision/explant procedure, if completed, and investigation of returned components, if available.

Event Description

Subject participating in (b)(6) experienced low impedance of posterior lead.Subject reported red light on external mobile charger during a clinic visit on (b)(6) 2015.Interrogation of the device indicated error codes including low rnr and posterior tip to ring short.Error codes were cleared, and therapy was delivered until (b)(6) 2015.The subject was unable to charge with the mobile charger, so the mobile charger was replaced; temporarily resolving the low rnr battery issue.The importance of regular charging was emphasized to the subject.On (b)(6) 2015, posterior tip to ring shorts were reported.Review of log data indicate shorts on (b)(6) 2015.On (b)(6) 2015, it was determined the low impedance state would persist and prevent therapy delivery, and the need for surgical revision was initially recommended.Therefore, this event was then determined, on (b)(6) 2015, to be a reportable event.A follow-up report will be filed after completion of the revision/explant procedure, if completed, and investigation of returned components, if available.Update: the maestro rechargeable system was explanted uneventfully on (b)(6) 2015.The subject was hospitalized overnight, so the device malfunction was considered as a serious adverse event.The event was adjudicated by the clinical events committee as related to the device.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: katherine tweden ; 2800 patton road; saint paul, MN 55113 ; 6516343209
• MDR Report Key: 5181543
• MDR Text Key: 29636152
• Report Number: 3005025697-2015-00002
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2014
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: 11580-1592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 99