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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018; explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial/lot #: (b)(4), ubd: 03-oct-2020, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 26-sep-2020, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2019, (b)(6): information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that visualization of the pocket site led to a diagnosis of an infection and histology confirmed it.The patient underwent a successful explant of the infected leads and generator/the entire system was removed and the issue was resolved at the time of the report.It was noted that the patient would be allowed to recover for 2 months and consider re-implant at that time.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the pocket was seeded, so to prevent intra-abdominal spread, both the leads were removed.The infection was noted to be enterobacter, staph aureus that originated from a j tube.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.The implantable neurostimulator (ins) (serial number (b)(4)) and leads (serial numbers (b)(4)) were returned and analysis found no anomalies.If information is provided in the future, a supplemental report will be issued.

• 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: 8282538
• MDR Text Key: 134254258
• Report Number: 3004209178-2019-01866
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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): Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 66