MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Paresis (1998)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2018, product type: lead, other relevant device(s) are: product id: 4351, serial/lot #: (b)(4), (b)(4): 92 pertain to product id 37800, serial# (b)(4), product type intestinal stimulator (b)(4), serial# (b)(4), product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient had chronic apathic gastroparesis and had a longstanding gastric stimulator that stopped working recently; it was suspected that the battery was no longer functioning.The patient had a worsening of symptoms and presented for a generator replacement along with pyloroplasty.It was noted that there were adhesions around the stimulator leads and the stimulator was queried and had irregular readings consistent with a failing generator.It was reported that on careful dissection and exposure of the antrum and duodenum, one of the leads was noted to have deteriorated insulation and was damaged, and it was therefore divided and withdrawn.The generator was explanted and removed from its fibrous pockets, the leads were detached, and the defective lead was withdrawn and discarded.A new lead was opened and inserted into the abdominal cavity and implanted 1 cm from the remaining lead parallel and secured peripherally to the stomach wall.Endoscopy was performed to make sure that there was no transmucosal migration and once reassured that there was not, the new lead was connected to the new generator.The generator was queried, impedance was 584 and nominal settings.The skin was closed and the stimulator was once again queried, turned on, and left at nominal settings.It was noted that the patient tolerated the procedure well with no apparent complications.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation of concomitant products: product id 4351, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient started experiencing the worsening symptoms on (b)(6) 2018.They noted that there were no abnormal impedance readings at all.It was also noted that a cause was not determined for the issues.The leads were okay in 2009, but it was found that they deteriorated during the 2018 surgery.There was no indication of a lead problem with interrogations ranging from (b)(6) 2018 to present; the impedance measurements were within range for all lead pairs.The generator was discarded and was not going to be sent back.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7634335
• MDR Text Key: 112195957
• Report Number: 3004209178-2018-14214
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/02/2018
• Date Device Manufactured: 06/25/2015
• 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 Weight: 57