MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Dyskinesia (2363)

Event Date 04/08/2016

Event Type  malfunction  

Event Description

A consumer reported that the implantable neurostimulator (ins) bulged out because the ins was too big for the patient¿s frame and size.The patient was a small woman and the ins showed above their breast.The patient did not like explaining the ins and telling them what it is.The patient had sudden pain in their right breast and the implant area hurts.The ins was ¿kind of moving¿ under the skin and they had ¿ligaments type of pain.¿ on the day prior to this report, the patient went to the market, worked out, and carried heavy things.Last night, the patient¿s right breast was hurting all night so they iced it.On the day of this report, the patient did not feel too much pain.There were no falls or traumas related to the event and there was no issue related to positional movement.The patient¿s health care provider (hcp) had recommended the patient work out 40 minutes a day, but they did not say what exercises.The patient¿s indication for use is dystonia and movement disorders.

Manufacturer Narrative

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

Additional information was received from a patient.It was reported that the circumstances that led to the breast plain included the patient having dystonia and tardive dyskinesia.The patient also stated that the pain and implantable neurostimulator (ins) movement are still on going.The patient also reiterated that the implantable neurostimulator (ins) was too big and it still sticks out under her arm.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 5866884
• MDR Text Key: 51848504
• Report Number: 3004209178-2016-16611
• Device Sequence Number: 1
• Product Code: MRU
• 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,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Date Device Manufactured: 12/08/2015
• 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: 55 YR