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

Model Number 37601

Device Problem Unstable (1667)

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

Event Type  Injury  

Event Description

It was reported that there was a flipped battery.There was no alleged product issue.Action required as result of the event was a revision.The battery would be unflipped and sutured down better.No diagnostic testing or troubleshooting was required.Patient was alive with no injury.Patient symptoms associated with the event were unknown.Additional information received reported the cause of the flip was unknown.Revision surgery was performed.It was unknown how the patient was doing or if they were receiving therapy.Nothing was explanted.It was later reported that 2 months prior to (b)(6) 2014 the device flipped out of its place and the patient had to grab it and put it back in place.It was noted that the revision surgery was done on (b)(6) 2014.Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead; product id 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.(b)(4).

• 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: 3827275
• MDR Text Key: 4453350
• Report Number: 3004209178-2014-09469
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2014
• Date Device Manufactured: 10/02/2013
• 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
• Patient Outcome(s): Required Intervention