MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health insurance source via a manufacturer representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported the patient had problems with the therapy.The clinician indicated replacement.During replacement of the neurostimulator, problems with the lead were determined.It was unknown if there were any environmental/extern al/patient factors that may have led or contributed to the issue.It was unknown if any diagnostics or troubleshooting was performed.The interventions taken to replace the issue included replacement of the lead and ins.The issue was resolved at the time of the report.No further details were known.A defective lead was noted; however, there was also a conflicting report that it was unknown if the lead was defective.It was unknown if the ins had to be replaced due to battery depletion or due to another reason.There was no further patient complication associated with the event.

Manufacturer Narrative

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

Event Description

Additional information was received from the physician via the manufacturer representative.It was reported that the lead model and lot number was asked but unknown.The physician clarified that no replacement of the ins occurred.The patient experienced a loss of therapy.The lead was defective and was replaced.There was no data available regarding the impedance measurements prior to the replacement.After the replacement, the patient profited from the therapy again.It was indicated that the lead should have been returned but the status was unknown.The ins had not been returned.

Manufacturer Narrative

Report source was updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 7153104
• MDR Text Key: 96002832
• Report Number: 3007566237-2017-05335
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• 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