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

Model Number 37601

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3387s-40, lot # v159776, implanted: (b)(6) 2008, product type lead; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 3387s-40, lot # v159776, implanted: (b)(6) 2008, product type lead; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2008, product type extension.

Event Description

A consumer reported via a manufacturer representative that over the past few months they had a sharp, electrical feeling under their left breast.The patient felt a stinging and a very hurtful feeling where the wires ran down in their chest where their breast would have been if they did not have a mastectomy.The patient could not specify what triggered the feeling and they felt the sensation no matter what position they were in.The patient had lost about 35 pounds over last six weeks and the patient felt the implantable neurostimulator (ins) battery moves around more.The ins was implanted in the patient¿s belly and they had a long extension.Three years prior to this report, the patient had a mastectomy and reconstruction.No recent falls or trauma had been reported.Impedance testing was done on both sides in a sitting and standing position.All impedances were measured to be within normal limits.The intermittent shocking sensation remained strong even with the ins turned off for two minutes.No interventions were taken.The patient¿s health care provider (hcp) was ordering an x-ray and a follow up appointment was being scheduled.The patient did have a mammogram scheduled for (b)(6) 2016.The patient did not feel comfortable making any adjustments to their stimulation.The patient recently had a ct scan and x-ray while they were in the emergency room a week and a half prior to this report.The imaging was unrelated to the patient¿s device or therapy.On (b)(6) 2016, the patient¿s hcp reported the ins pocket site had been pinching the patient.The ins pocket site appeared intact with no redness or swelling.The hcp did not think the ins was moving, but the patient could feel the device moving.The issue was not resolved and the patient was alive with no injury at the time of this report.The patient¿s indication for use is parkinson¿s dual and movement disorders.

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: 5912126
• MDR Text Key: 53442144
• Report Number: 3004209178-2016-17798
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• Date Device Manufactured: 03/30/2015
• 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: 73 YR