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

Model Number 37612

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387-40, lot# j0209786v, implanted: (b)(6) 2002, product type: lead.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 64001, lot# n309308, implanted: (b)(6) 2014, product type: adapter.Product id: 3387-40, lot# j0209786v, implanted: (b)(6) 2002, product type: lead.(b)(4).

Event Description

It was reported that the patient experienced a head pulling sensation.She felt her head pulling backward, almost to her shoulder, and there was lots of pain behind her ears.She also had trouble walking and pain by the devices.The pulling issue occurred daily in the past week and was considered sudden.The patient did not really know the circumstances that led to the sensation.She checked her device with her programmer the day prior to the report and it said "on and okay." the stimulation was also on and the device was charged.The patient called her doctor on (b)(6) 2105.She was told to keep checking her devices and had an appointment scheduled for (b)(6) 2015 to see her doctor.The patient outcome and any interventions were not reported, so additional information will be requested after the patient's doctor appointment.If additional information is received a supplemental report will be sent.Refer to manufacturing report #3004209178- 2015-13688 as the patient had two inss and it was unknown which one was the source of the issues.

Event Description

Additional information received from a consumer reported the patient's health care provider (hcp) checked to see if the implantable neurostimulators (ins) had a kink in the wire.The hcp gave the patient extra injections in their neck to see if that would help.The injections helped a little, but the patient's head was still pulling.

• 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: 4925716
• MDR Text Key: 22515121
• Report Number: 3004209178-2015-13691
• Device Sequence Number: 1
• Product Code: MRU
• 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
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Date Device Manufactured: 12/20/2013
• 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