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

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Battery Problem (2885); Environmental Compatibility Problem (2929)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the patient¿s implantable neurostimulator (ins) and therapy turned off and the patient was not sure why.The ins had been intermittently turning off.The ins was about 75 percent charged and the patient was able to use the patient programmer to turn therapy back on.The patient had been road traveling to different hotels and was at a concert when they found out that therapy was turned off.The patient went to recharge the ins and they noticed that the therapy was off.An impedance check was done in april and it seemed fine.The ins had not turned off since the patient was at a concert.The patient met with their healthcare professional (hcp) and the ins was checked with a clinician programmer.Codes were seen on the clinician programmer.The cause of the event was not determined.The patient later reported the ins battery was at 75 percent charged and the following day it was 25-50 percent charged.The ins had also turned itself on its own twice.The patient had recovered without permanent impairment.No interventions 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 products: product id: 37651, serial# (b)(4), product type: recharger.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 3387s-40, lot# v556377, implanted: (b)(6) 2010, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3387s-40, lot# v270501, implanted: (b)(6) 2010, product type: lead.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

Event Description

Additional information received reported that the patient's device turned off while in (b)(6) and the patient had a loss of therapy.

• 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: 4747569
• MDR Text Key: 5886661
• Report Number: 3004209178-2015-08438
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Date Device Manufactured: 05/14/2014
• 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: 00021 YR