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

Model Number 37601

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

It was reported the night prior to this report, the patient started feeling a vibration in their right arm at the inside of their elbow every ten seconds.The patient¿s pain level was a three on a scale of 1-10.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Event Description

Additional information reported that the patient did not have concerns with their device or therapy now.The patient received assistance from their healthcare professional or manufacturer representative on 2015 (b)(6) and their concerns were resolved.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va0gvdy, implanted:(b)(6) 2014, product type: lead.Product id: 3387s-40, lot# va0gvdy, implanted: (b)(6) 2014, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension.Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the health care professional (hcp) that reported the patient experienced vibration and shock-like pain at the right inner elbow for 9-10 seconds for approximately 6 hours on (b)(6) 2015.It was noted this resolved.The patient also experienced shock-like pain and vibration at the left heel for 9-10 seconds for 90 minutes.Troubleshooting included reprogramming and device interrogation.The patient recovered without permanent impairment.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4882932
• MDR Text Key: 6062247
• Report Number: 3004209178-2015-12559
• 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: Consumer,consumer,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• Date Device Manufactured: 03/24/2014
• 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: 00071 YR