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

Model Number NEU_INTERSTIM_INS

Device Problems Overheating of Device (1437); Device Or Device Fragments Location Unknown (2590); Electromagnetic Compatibility Problem (2927)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 388928, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 388928.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the consumer via the manufacturer representative (rep) reported heating at the level of the lead (sacrum a nd spine).Factors that may have led or contributed to the issue reported electromagnetic interference (emi) from a music amplifier.Diagnostics/troubleshooting reported that the material must be explanted.It was unknown if the issue was resolved and no additional information was provided.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 388928, lot# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the stimulator was explanted but the lead was always implanted.Electromagnetic interference (emi) compatibility with the lead left in situ.No further complications were reported/anticipated.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 7549418
• MDR Text Key: 109404108
• Report Number: 3007566237-2018-01593
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 06/13/2018
• 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