MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PRIMEADVANCED; STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Model Number 37702

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Literature citation: guentchev m, preuss c, rink r, peter l, sailer mhm, tuettenberg j.Long-term reduction of sacroiliac joint pain with peripheral nerve stimulation.Operative neurosurgery.2017;13(5):634-639.Doi: 10.1093/ons/opx017 a2: this value is the average age of the patients reported in the article as specific patients could not be identified.Any known age related information has been included.Please note this date is based off of the article¿s publication date as the specific event date was 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.Section d information references the main component of the system from the first event; other applicable components are: product id neu_unknown_lead lot# unknown serial# implanted: explanted: product type lead product id 37702 lot# unknown serial# implanted: explanted: product type implantable neurostimulator d2: device used for off label indication.The indication the device was used for was for the treatment of sacroiliac joint pain through peripheral nerve stimulation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Article summary: the article¿s objective was to investigate the long-term (up to 4 years) response rate of peripheral nerve stimulation (pns) for therapy-refractory sacroiliac joint (sij) pain.Sixteen consecutive patients with therapy-refractory sij pain were treated with pns and followed for 4 years in 3 patients, 3 years in 6 patients, and 2 years in 1 patient.Quality of life, pain, and patient satisfaction were assessed using the oswestry disability index 2.0, visual analog scale (vas), and international patient satisfaction index.Patients reported a pain reduction from 8.8 to 1.6 (vas) at 1 year (p<(><<)>.001), and 13 of 14 patients (92.9%) rated the therapy as effective (international patient satisfaction index score = 2).At 2 years, average pain score was 1.9 (p <(><<)>.001), and 9 of 10 patients (90.0%) considered the treatment a success.At 3 years, 8 of 9 patients (88.9%) were satisfied with the treatment results, reporting an average vas of 2.0 (p <(><<)>.005).At 4 years, 2 of 3 patients were satisfied with the treatment results.The authors concluded that pns is a successful long-term therapy for sij pain.Reported events: 1.1 patient (patient 01) experienced pain recurrence after 6 months.The patient had reported initial success with their device, but later experienced ¿at least one episode of preoperative levels of pain during the follow-up period.¿ the patient was reported to have not experienced effective therapy at their 12, 24, 36, and 48 month follow-ups and the ¿treatment was considered to be a failure¿ as a result.The issue was not due to termination of sij stimulation.It was noted the patient was implanted in (b)(6) 2012 at the age of (b)(6) and their system was ultimately explanted in (b)(6) 2015.One (1) patient (patient 06) experienced the ¿breakage¿ of their lead and required lead replacement.It was noted the patient¿s implantable neurostimulator (ins) was replaced at that time also.It was noted the patient was first implanted in (b)(6) 2012 at the age of (b)(6).3.1 patient (patient 06) experienced the backward migration of their lead and required lead replacement.It was noted the patient¿s ins was replaced at that time also.It was noted the patient was first implanted in (b)(6) 2012-at the age of(b)(6).There were no further complications reported or anticipated.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (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: 6973916
• MDR Text Key: 90114613
• Report Number: 3007566237-2017-04535
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2017
• 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: 74 YR