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

Model Number 37800

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Impaired Healing (2378); Tissue Breakdown (2681)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient had a battery placed on (b)(6) 2018 and developed a hematoma with infection and bleeding.It was noted that the infection cleared up but left an open wound above the battery location and exposed the battery.The hematoma was reported to have led or contributed to the issue.The patient would have their battery removed in a few weeks.No further complications were reported/anticipated.

Manufacturer Narrative

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 battery removal had been scheduled and the patient was on antibiotics for the infection prior to the exposure.It was noted that the device was unaffected.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d11: product id 435135 lot# serial# (b)(4) implanted: explanted: 2018-(b)(6) product type lead product id 435135 lot# serial# (b)(4) implanted: explanted: 2018-(b)(6)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 leads had eroded through the patient's thin skin.Prior to this, the battery was removed secondary to exposure.The skin did not heal.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), explanted: (b)(6) 2018, product type: lead; product id: 435135, serial# (b)(4), 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 manufacturer representative (rep).It was reported that the wires were coming through the skin.The patient was having them cut out on (b)(6) 2018.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp.It was reported that the battery was removed on the day of the report.

• 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: 7690356
• MDR Text Key: 114057609
• Report Number: 3004209178-2018-15815
• 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,Followup
• Report Date: 10/26/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 07/17/2017; 07/24/2018; 08/08/2018; 09/14/2018; 10/09/2018
• Supplement Dates FDA Received: 07/19/2018; 08/15/2018; 10/02/2018; 10/04/2018; 10/26/2018
• Date Device Manufactured: 03/06/2018
• 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): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 40