MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Headache (1880); Neuropathy (1983); Pain (1994); Scar Tissue (2060)

Event Date 12/20/2014

Event Type  Injury  

Event Description

Yin, s., jin, w., de salles, a.Occipital-device-related pain as a complication of deep brain stimulation.British journal of neurosurgery.2015 feb 7 2015:1-3.Summary: deep brain stimulation is an established treatment for movement disorders.We reported 4 patients (1.3%) of postoperative occipital headache related to the placement of the connection among 309 patients from 1998 to 2008.The patients were treated successfully by repositioning the connector into a groove created in the bone.Reported event one (b)(6) female patient with left side deep brain stimulation (dbs) for dystonia experienced post-operative occipital neuralgia considered to be caused by the placement of the connector wire.The patient reportedly had a unilateral retro-auricular headache in the location where the connector was implanted first occurring 6 months after implant.The patient did not experience infection or inflammation in the location of the connector wire and had no history of headache before the dbs operation.The reporter stated that the connector and wire were found to have drifted from the original operation site; the migration of the connector was noted to be ¿moderate.¿ the patient underwent surgical revision as a result.A high-speed drill was used to make a depression in the bone to completely cradle the connection system.Once this was completely molded and prepared, the connection system was placed inside the groove.The wires of the deep brain stimulator were completely connected during the surgery.The connector was then sutured to the fascia.The re-operation was performed 8 months after initial dbs system implantation, and within 1 month after the report of occipital pain.The reporter stated that it was likely that scar tissue forming around the connector interfered with the branches of the occipital nerves; when the connector migrated, the nerve branch was pulled, thus causing pain.The patient may have had irritation of the branches of the greater and/or lesser occipital nerve, resulting in pain near the connector.It was noted that there was no damage to the connector wire found.The patient¿s pain was reportedly relieved soon after the connector was replaced into the groove in the skull.The source literature did not include any specific device information.Further information has been requested; a supplemental report will be submitted if additional information is received.See attached literature article.

Manufacturer Narrative

Please note that this date is based off of the date that the article was accepted for publication as the 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 events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about patient information and additional information regarding the reported events.Concomitant product: product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_ext, lot # unknown, product type extension.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported that according to a physician involved with the case the event was ¿not related to any quality problem¿ with the products involved and instead the cause of the issue was ¿the position of the extension placed in the surgery.¿.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4664774
• MDR Text Key: 5733883
• Report Number: 3007566237-2015-00904
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2015

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_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2015
• Initial Date FDA Received: 04/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• 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: 00027 YR