MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37602

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: neu_unknown_lead, lot#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Takashi asahi, kiyonobu ikeda, jiro yamamoto, nobutaka yamamoto, shuji sato, hiroyuki tsubono, yuko muro.Doi.Org/10.1016/j.Parkreld is.2021.05.009 abstract: we report two cases of granuloma that occurred around an implantable pulse generator (ipg) for deep brain stimulation.Both cases showed no signs of infection and disappeared after moving the ipg and removing the granulation.If a noninfectious mass is formed, the relocation of ipg may improve it.  reported events: it was reported that the patient's lead got infected after 4 years and 9 months of dbs, and therefore it was removed and reinserted.After 5 years and 3 months of dbs, the ipg protruded to the left side and moved under the left pectoralis major fascia.Five years and nine months following the first dbs, a mass appeared around the left igp and gradually increased.After 6 years and 3 months of the first dbs, the mass became indurated, partly discolored, and thinned.Blood samples did not reveal any signs of inflammation, such as increase in leukocytes and crp.Surgery was performed to avoid tearing of the skin.The ipg was removed; furthermore, the granulation tissue was removed to the extent possible.A long extension was passed from the back of the left auricle to the abdomen and the same model of ipg was placed on the left lower abdominal fascia.No signs of infection were observed and no bacteria were detected in culture.The pathological diagnosis was granuloma (fibrous tissue with mild inflammation).Subsequently, the induration disappeared with no recurrence for 7 years.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.Please see attach literature article.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 12363214
• MDR Text Key: 268040197
• Report Number: 2182207-2021-01468
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• 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
• Patient Age: 63 YR