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

Model Number	2200P-47E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Abdominal Pain (1685); Erosion (1750); Nausea (1970); Internal Organ Perforation (1987); Perforation (2001); Seroma (2069); Vomiting (2144); Constipation (3274)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 5667963
• Report Number: 3005025697-2016-00003
• Device Sequence Number: 218898
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2016
• Initial Report FDA Received Date: 05/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 113