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

Model Number 37601

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Date 07/11/2016

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with a neurostimulator for movement disorders.It was reported that the patient was told by the health care provider (hcp) that in order to conserve the battery, the patient should turn stimulation off at night as the patient did not experience shaking during this time.However, when the patient turns the stimulation on in the morning, he experiences a tingling sensation all the way through his body.The patient confirmed that the sensation dissipates with time and that the issue started 3-4 months ago.Mri guidelines due to an unrelated knee problem was also requested.

Event Description

Follow up information received from the patient reported that the patient did not turn stimulation off in the first year after implant, with the hcp saying that the patient was wasting battery life as a result.The first time the patient shut stimulation off was in (b)(6) 2016, and when they turned it on they felt a very mild tingling from head to toe.The patient believes the manufacturer representative (rep) told them the tingling was normal so they do not have to worry about it.It was stated that the tingling sensation has resolved, with the patient indicating it is still there but does not bother them.

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: 6142224
• MDR Text Key: 61353610
• Report Number: 3004209178-2016-25067
• 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,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Date Device Manufactured: 08/26/2015
• 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: 70 YR