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

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Effects, Unexpected (2099)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va0tyzy, implanted: (b)(6) 2015, product type lead.Product id: 3389s-40, lot# va0shxj, implanted: (b)(6) 2015, product type lead.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

A consumer reported that the patient had one side done first and it was helping some, and 1-2 months before they wanted to put the second implantable neurostimulator (ins) an mri was performed to make sure everything was in place.It was determined that the leads from the first ins had moved, and when they implanted the second ins they moved the leads from the first ins as well in (b)(6) 2016.It was further mentioned that the patient has been living with being spastic for the past 8 months prior to date notified and they have no therapy.No further complications are anticipated.The patient's indication for implant is dystonia and movement disorders.

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6422268
• MDR Text Key: 70515290
• Report Number: 3004209178-2017-06083
• 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: 03/21/2017

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: 07/28/2016
• 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: 02/22/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 02/22/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 02/11/2015
• 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: 16 YR