MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); Discomfort (2330)

Event Date 11/19/2014

Event Type  Injury  

Event Description

It was reported the patient was in the hospital since (b)(4) 2014 with a headache and sharp pains in their head and neck.The patient was not sure if it was related to their device or therapy.When the patient was in the shower and washing their hair, they hit a really tender spot when they were scrubbing their scalp.The patient felt the tenderness ¿three fingers¿ from the tip of their ear.The patient had called their healthcare professional (hcp) and they stated that where the patient felt the pain was where the connector was implanted.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.

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3389s-40, lot# va00cfp, implanted: (b)(6) 2012, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient was in the hospital and they did not have their patient programmer with them.The patient did not have a 50 percent or greater symptoms reduction.The nurse had contacted a manufacturing representative to come and check the patient's devices.The healthcare professional (hcp) stated the patient's system was working when they met with the patient on (b)(6) 2014.No further actions were required and the patient had recovered without permanent impairment.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4318262
• MDR Text Key: 5256126
• Report Number: 3004209178-2014-23658
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2014
• Date Device Manufactured: 08/01/2011
• 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 Outcome(s): Hospitalization
• Patient Age: 00053 YR