MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

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

Patient Problems Bacterial Infection (1735); Erythema (1840); Complaint, Ill-Defined (2331); Impaired Healing (2378); Fluid Discharge (2686)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, the patient ¿presented to his local hospital with an infected chest incision¿ and device pocket.The patient was transferred to another hospital where he received ¿intravenous antibiotics and treatment¿ and had his ¿chest implantable neurostimulator (ins) removed.¿ then, during a follow-up visit on (b)(6) 2014, it was found the patient¿s extension was ¿protruding behind his left ear.¿ additionally, it was noted the right burr hole was ¿reddened and weeping¿ at that time.The patient reported that had been ¿going on a few weeks¿ prior to the follow-up visit.The patient was administered additional antibiotics at that time and was admitted to the hospital as a result.The following day, the patient¿s system hardware was revised and the patient was again administered intravenous antibiotics and their ¿home course was completed.¿ however, it was reported that on (b)(6) 2014, the patient¿s incisions were notably ¿still not healing¿ and their remaining system hardware was removed as a result.There was notably ¿no alleged product issue¿ with the explanted devices.The patient was alive with no injury at the time of report.The patient¿s infection had reportedly ¿resolved¿ at the time of report.The patient was implanted with a full, new system four days after initial report and was receiving effective therapy as of 22 days after initial report.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant products: product id: neu_unknown_ext, lot# serial# unknown, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: extension.Product id: neu_unknown_ext, lot# serial# unknown, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: extension.Product id: 3389-40, lot# 0207343315, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.Product id: 3389-40, lot# 0207314831, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 4330618
• MDR Text Key: 5256833
• Report Number: 9614453-2014-03109
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2013
• 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): Hospitalization; Required Intervention