MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Gangrene (1873); Foreign Body In Patient (2687)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# unknown, product type lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020 rtg0066822 (hcp): information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had developed gangrene as a result of the small intestine getting entangled with the lead wire.No further patient complications were reported as a result of this event.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10363162
• MDR Text Key: 201573502
• Report Number: 2182207-2020-00642
• Device Sequence Number: 1
• Product Code: LNQ
• 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
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• 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