MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Itching Sensation (1943); Complaint, Ill-Defined (2331)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 3387s-40, lot# va0u148, implanted: (b)(6) 2015, product type: lead; product id 3387s-40, lot# va0u148, implanted: (b)(6) 2015, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.

Event Description

Information was received from a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the patient's implantable neurostimulator (ins) was moving around and sticks out when they go to bed.The patient stated that she "works it back down" when this occurs.It was also reported that their wires feel like they were knotted up and the burr holes on her skull itch when she washes her hair; this has been occurring since implant.It is unknown when the ins moving around and poking out, and the wires knotted up began occurring.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6089338
• MDR Text Key: 59574638
• Report Number: 3004209178-2016-23503
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

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 Expiration Date: 08/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: 10/18/2016
• Supplement Dates FDA Received: 09/27/2017
• Date Device Manufactured: 02/27/2015
• 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 Age: 63 YR