MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Decreased Peak Expiratory Flow rate (2435); Shaking/Tremors (2515)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

It was reported the patient had a loss of therapeutic effect and their spasms had come back the day of this report.It had been a long time since the patient had checked the implantable neurostimulator (ins).The primary cell ins had lasted several years and the patient wanted to check the ¿lights.¿ the patient did not have any problems with their rechargeable ins.The patient had been battling lung cancer and their tremor had been horrible so they wanted to make sure the ins was working.When the patient checked the ins with the patient programmer, the green light next to the stimulation on was lit and the 9v battery was lit.There was no light next to the ins battery light.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.Refer to manufacturer report #3004209178-2015-01338.

Manufacturer Narrative

Concomitant products: product id 7428, serial # (b)(4), implanted: (b)(6) 2011, product type implantable neurostimulator; product id 3387-40, lot # j0327188v, implanted: (b)(6) 2003, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 37651, serial # (b)(4), product type recharger; product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension; product id 3387-40, lot # j0327188v, implanted: (b)(6) 2003, product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4460281
• MDR Text Key: 20296761
• Report Number: 3004209178-2015-01339
• 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
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Date Device Manufactured: 06/08/2012
• 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: 00061 YR