MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_INTERSTIM_INS

Device Problem Battery Problem (2885)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.

Event Description

Lagares-tena, l., munoz-duyos, a.Use of a new plasma scalpel during pulse generator implant and replacement in neuromodulation.Cogent medicine.2017.4: 1353248.Doi: 10.1080/2331205x.2017.1353248 summary: sacral neuromodulation (snm) is a minimally invasive therapy for defecatory disorders.Peak plasma blade¿ (medtronic) has been used as an alternative to the conventional electric scalpel and scissors in 3 procedures of neuromodulation.Peak plasmablade¿ uses less total energy, operating at significantly lower temperatures than electrosurgical technology.No damage to the wires or pulse generators or patient complications were detected during the surgery or follow-up.A reduction in the duration of the procedures was noted.Reported events: a (b)(6) woman was diagnosed with severe neurologic fecal incontinence.The patient was implanted after a successful tined lead test in 2010 in the left s3 nerve root.After five years, the patient referred a relapse in her symptoms.Low battery level was detected and a pg exchange was performed.No specific device information provided.

Manufacturer Narrative

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

• Brand Name: NEU_INTERSTIM_INS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7152056
• MDR Text Key: 95959763
• Report Number: 3007566237-2017-05333
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

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 Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/03/2018
• 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: 51 YR