MAUDE Adverse Event Report: MEDTRONIC ACTIVA PC+S; ACTIVA PC + S

Model Number ACTIVA PC+S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Pain (1994); Seizures (2063)

Event Date 01/05/2018

Event Type  Injury  

Event Description

After consenting, study subject underwent surgical placement of dbs for treatment of chronic pain, in stage 1, the dbs leads were placed without difficulty and were placed successfully in the target locations, and leads were tunneled to separate incision for stage 2 of surgery for internalization of the pulse generator (battery).Routine intraoperative ct scan taken to verify dbs electrodes location also revealed an incidental moderate intracerebral hematoma in a part of the cavity created by her old stroke.The hematoma was contained there, and did not cause mass effect on the adjacent normal brain tissue.In stage 2 of the surgery, we reopened the parietal incision in preparation for tunneling the electrode leads to the pulsa generator in the chest.Since the incision was over the site of her previous surgery, we checked the site of the hematoma and found that there was no active bleeding, and that the brain was pulsatile without sigs of pressure.The leads were then tunneled to the chest pocket and connected to the pulse generator in the chest.There were no clinical or observable sequela from the bleeding likely because it occurred in previously infarcted tissue.After surgery, she had no new neurological deficit after (no weakness or change in neglect), when compared to baseline.She recovered as expected, and was discharged to acute rehab as expected.Her neurological exam on discharge was not significantly different from her preoperative exam.Separately, she had 3 short (<30 sec) seizures immediately after surgery involving transient twitching of her l face and arm which resolved with iv ativan.After starting an antiseizure medication (keppra), she experienced no further seizures or side effects from the medication.The bleeding was probably related to the study procedure, but not likely related to electrode implant or generator implant, as it occurred far from the sites of the primary surgery.The risk of bleeding is a known risk of dbs surgery, and has been seen in up to 2-3% of cases in the literature.This was listed on the consent form as a rare side effect, and in this pt it did not have any clinical consequence.Her recovery was as expected, and all other aspects of hospitalization proceeded as expected.The seizures were probably caused by pneumocephalus which is listed as a "less likely" risk in the consent form.These are known risks which were described prior to surgery.

• Brand Name: ACTIVA PC+S
• Type of Device: ACTIVA PC + S
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55448
• MDR Report Key: 7221413
• MDR Text Key: 98462342
• Report Number: MW5074877
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: ACTIVA PC+S
• Device Catalogue Number: 37604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 62