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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Erosion (1750); Headache (1880); Unspecified Infection (1930); Insufficient Information (4580)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Literature citation: lagrata s, cheema s, watkins l, matharu m.Long-term outcomes of occipital nerve stimulation for new daily pers istent headache with migrainous features.Neuromodulation.2020.Doi: 10.1111/ner.13282 literature abstract: new daily persistent headache (ndph) is a subset of chronic headache where the pain is continuous from onset.Phenotypically it has chronic migraine or chronic tension type features.Ndph is considered to be highly refractory.Occipital nerve stimulation (ons) has been used for treatment of refractory chronic migraine but there are no specific reports of its use for ndph with migrainous features.Nine patients with ndph with migrainous features were identified as having had ons implants between 2007 and 2014 in a specialist unit with experience of using ons in chronic migraine.Moderate to severe headache days were compared at baseline and follow-up.A positive response was defined as at least 30% reduction in monthly moderate to severe headache days.The authors concluded that their experience suggested that ons is not effective in the treatment of ndph with migrainous features even in centers with experience in treating chronic migraine with ons.The difference in response rates of chronic migraine and ndph with m igrainous features supports the concept of adifferent pathophysiology to the two conditions.This value reflects the sex of the majority of the patients reported in the article as specific patients could not be identified.Please note this date is based off of the article¿s acceptance date as specific event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Device used for off label indication.The indication the device was used for was occipital nerve stimulation (ons) for the treatment of new daily persistent headache (ndph).Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator, product id: neu_unknown_lead, lot#: unknown, product type: lead.From the first event; other applicable components are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: asku, udi#: (b)(4), product id: neu_ins_stimulator, serial/lot #: unknown, ubd: asku, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Reported events: 1.7 unknown adverse events were reported that required additional surgical input.2.1 patient (patient 1) experienced an electrode erosion a month after implant which required surgical revision.3.1 patient (patient 5) experienced an infection over a lead connector which resulted in the removal and subsequent reinsertion of the whole ons system.4.One patient (patient 7) experienced three repeated battery failures after only 5¿6 months.This led to a revision and replacement of the ons system with a rechargeable device.5.1 patient (patient 5) experienced a ¿battery failure¿ that required device replacement.The patient had experienced a ¿clinically significant reduction in moderate to severe headache days¿ with a positive response observed within three months of implant and maintained through follow-up while the device was operational.However, ¿at 18-20 months postimplant, the patient¿s implantable neurostimulator (ins) failed.¿ it was stated that ¿battery failure was associated with an increase in headache frequency so that within four months he was back to baseline in terms of his monthly moderate to severe headache days.Following battery replacement, it took a further 6-8 months to regain the previous levels of benefit.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 11247748
• MDR Text Key: 233735466
• Report Number: 2182207-2021-00158
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P840001
• 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
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• 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