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

Model Number 2200P-47E

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Erosion (1750); Nausea (1970); Internal Organ Perforation (1987); Perforation (2001); Seroma (2069); Vomiting (2144); Constipation (3274)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

The radio frequency (rf) based system evaluated within the (b)(4) trial is not commercially available.The rf system neuroregulator incorporates is-1 compatible sockets connected to the neuroregulator enclosure via lead extensions (approximately 17 cm in length) which make the connection to the anterior and posterior leads.The is-1 compatible sockets on the rf system are bulky in comparison to the implantable leads and are attached at the end of the rf neuroregulator.Because of the length of the lead extensions and the location of the sockets, they are always placed through the abdominal wall into the abdomen.This is in contrast to the commercially available maestro rechargeable system, in which only the leads are placed through the abdominal wall into the abdomen.As a result, the additional weight of the is-1 compatible sockets within the abdomen can cause additional force on the implanted leads in the non-commercially available rf system compared to the commercially available maestro rechargeable system.This additional force, as well as the additional length of the lead extensions with the rf system may result in a higher risk of erosion complications than the commercially available maestro rechargeable system.Importantly, there have been no reported cases of lead erosion to date with the commercially available maestro rechargeable system, with experience in over (b)(4) implanted cases with up to 7 years of follow-up.Within (b)(4) total worldwide implants of the rf system, with as much as 10 years of follow-up, only 3 issues that may be related to the additional length of the lead extensions and additional intra-abdominal force have been reported.This rf system remains implanted in (b)(6) subjects.Related mdr for anterior lead involvement in same event: 3005025697-2016-00002.

Event Description

A subject participating in the (b)(6) clinical trial was undergoing planned conversion to the commercial maestro rechargeable system on (b)(6) 2016.Prior to the procedure, the subject reported no complaints.During the conversion procedure, low ring to ring impedance was experienced.It was determined that portions of both the anterior and posterior leads (including both tip electrodes, one suture wing, and one ring electrode), which were originally implanted on (b)(6) 2008, had eroded into the lumen of the proximal stomach.All device components were removed.The gastrostomy created by the removal of the lead bodies was repaired per standard procedure and a drain placed.This subject was not converted to the maestro rechargeable system.The subject was hospitalized following this procedure and discharged on (b)(6) 2016 in good condition.The subject was re-admitted on (b)(6) 2016 for nausea, vomiting and constipation.White blood cell count was 13.A ct was done which showed small locules of gas and fluid near the area of the gastrostomy repair, as well as subcutaneous collection of fluid on the left flank, likely a seroma.An esophagram showed no evidence of leakage.The subject was treated with iv fluids and antibiotics and discharged on (b)(6) 2016 with oral antibiotics and stool softener.Refer to section additional narrative for description of difference of use of the leads with the non-commercialized system used in the (b)(4) clinical trial compared to their use within the commercially available maestro rechargeable system.A follow-up report will be completed after investigation of returned components, if available.

• 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: lisa pritchard ; 2800 patton road; saint paul, MN 55113 ; 6517892681
• MDR Report Key: 5667963
• MDR Text Key: 45571266
• Report Number: 3005025697-2016-00003
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2008
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C2-09265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 113