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

Model Number 37603

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.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

The patient reported that they are experiencing some tremor as of about (b)(6) and need help changing settings.Upon interrogation using the patient programmer (pp) it was found that the left implantable neurostimulator (ins) was on, and the right ins was off.Assistance was given resulting in the patient successfully turning the ins back on and changing pp from icon mode to text mode.It was stated that the patient was also experiencing tingling in their fingers on date notified, noting that they feel this sensation when turning therapy on, but it went away during the call.The patient had seen their healthcare provider (hcp) two weeks prior to date notified and they adjusted one ins and not the other.Follow up with the hcp is to be conducted.The patient's indication for implant is unknown.See related regulatory report 3004209178-2017-02949.

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6315783
• MDR Text Key: 67250653
• Report Number: 3004209178-2017-02950
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2017
• Date Device Manufactured: 07/08/2014
• 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: 68 YR