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

Model Number 37612

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Swelling (2091)

Event Type  Injury  

Event Description

It was reported that there was no alleged product issue, there was a pocket site infection.The patient had an upper arm infection that migrated to the battery pocket and had become inflamed.The implantable neurostimulator (ins) and extension were explanted.The lead was not explanted and it was planned to be reused if no infection was found/confirmed.The issue was resolved and the cause was determined, there was no device related product issue.A culture was taken from the device pocket, no organism was specified and it was unknown what type of infection it was.An antibiotic treatment was necessary.Symptoms had included redness and swelling at the device pocket, right side implant.Perioperative antibiotics were administered.Date of onset/diagnoses was unknown.The patient did not have meningitis.The patient was going to be hospitalized for a few days to be treated with antibiotics.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Event Description

Additional information received reported that the following information was pertaining to the patient¿s right side and not the left side.Preoperatively, prophylactic antibiotics were prescribed according to protocol.The wounds were irrigated with copious amounts of bacitracin and betadine intraoperatively.Postoperatively, antibiotics were administered via peripherally inserted central catheter (picc) line.

Manufacturer Narrative

Concomitant medical products: product id: 3391s-40, lot# v257753, implanted: 2010-(b)(6), product type: lead.Product id: 7482a51, serial# (b)(4), implanted: 2010-(b)(6), product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37651, serial# (b)(4), product type: recharger.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient had presented with cellulitis to the area of the implantable neurostimulator (ins) and it had partially eroded through the skin.Following the removal of the ins and extension the patient presented with a small area in the right parietal area with an exposed wire (lead) but no erythema, tenderness, or drainage.The patient underwent surgical removal of his deep brain stimulation (dbs) lead as it had eroded through the skin and was presumed to be infected as the bacteria cultured from the right lead site was identical to the bacteria found earlier at the right battery site.The patient acquired the infection following a skin biopsy of his arm.The infection resolved after removal.It was noted there were plans for bilateral re-implantation, but no date was provided.Information regarding the patient's infection of the right device system was reported with information regarding a previous infection of his left device system; follow up is being conducted for clarification.Refer to mfr report # 3004209178-2015-12721 for the event regarding the patient's left system.

• 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: 4643488
• MDR Text Key: 5616488
• Report Number: 3004209178-2015-05665
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Date Device Manufactured: 04/25/2012
• 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): Hospitalization; Required Intervention