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

Model Number 37601

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

Patient Problems Edema (1820); Seizures (2063); Swelling (2091)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported, the patient had a seizure monday night post operation and again on the day of this report.The patient had swelling and edema near the site of the contacts by one of the implanted leads.The implantable neurostimulator (ins) had not been programmed or turned on after implant.Impedances were run during the operation.A ct scan was done and the cause of the event was unknown.The patient was still in the hospital and the device was not on.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

Product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0hyjm, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0c4xs, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6) ; product type extension product id 37642, serial# (b)(4); product type programmer, patient.(b)(4).

Event Description

Additional information received reported the patient's device had not been turned on or programmed yet.The cause of the event was not determined and the patient was still recovering in the hospital.

• 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: 4298457
• MDR Text Key: 5058207
• Report Number: 3004209178-2014-22616
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2014
• Date Device Manufactured: 04/01/2014
• 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 Outcome(s): Other
• Patient Age: 00071 YR