MEDTRONIC MEDTRONIC 33875 ACTIVA RC 37612

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-26 for MEDTRONIC MEDTRONIC 33875 ACTIVA RC 37612 manufactured by Medtronic.

Event Text Entries

[18795132] Deep brain stimulator infection. Deep brain stimulator placed (b)(6) 2014. In (b)(6) 2014, she developed what appeared to be a pimple on the suture line in the left frontal area. An internal suture interrupted was removed and the area healed. In (b)(6) 2014, another pimple like spot appeared that progressed into a larger yellow fluid-filled blister that drained purulent and clear drainage a few days after being seen in clinic. It would then bleed then crust over and attempt to heal. On (b)(6) 2014, she was seen in the office for dbs programming session. She had a small left scalp area not yet healed. No redness, no drainage, but slightly tender to touch. Mom phone on (b)(6) 2014 to report the area seen on (b)(6) 2014 had burst a few days after the office visit. She now has a "blister area on her incision area" for more than a month. Mother reported she has an open wound on her head. Dr. (b)(6) suggested see him soon. Patient was seen in the office on (b)(6) 2014 by dr. (b)(6). Presented with a draining wound in her left frontal incision. No fever. Present for 2-3 weeks and not responding to local care. Recommended mri to r/o intracranial abscess. Mri findings were not suggestive of a dbs infection. Based on mri findings dr. (b)(6) recommended debridement in operation room. The plan would be debridement and excision of abnormal tissue with closure. He discussed the possibility of getting in there and finding increased infection underneath, at which point he would remove the entire dbs. Gentle scrubbing of the area to prep for surgery started pus coming from the site. This area broke down and came open. Family made the decision, in consult with dr. (b)(6), to remove the entire dbs. On (b)(6) 2014 dr. (b)(6) removed the entire dbs due to left scalp infection at frontal incision. Infectious diseases was consulted. Iv antibiotics were started. Patient remains inpatient at the time of this report. Plan includes placement of a picc line for long term antibiotics. Patient near baseline.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4285827
• MDR Report Key: 4285827
• Date Received: 2014-11-26
• Date of Report: 2014-11-20
• Date of Event: 2014-11-18
• Date Facility Aware: 2014-11-18
• Report Date: 2014-11-20
• Date Reported to FDA: 2014-11-20
• Date Reported to Mfgr: 2014-11-20
• Date Added to Maude: 2014-12-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDTRONIC
• Generic Name: DEEP BRAIN STIMULATOR
• Product Code: GYZ
• Date Received: 2014-11-26
• Model Number: MEDTRONIC 33875
• Catalog Number: ACTIVA RC 37612
• Lot Number: VA0CZMX
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC
• Manufacturer Address: MINNESPOLIS MN US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2014-11-26