MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems High impedance (1291); Low impedance (2285)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that a low impedance of 40 ohms was measured on electrode pair 4, 5.Telemetry printouts also indicated a low impedance of 156 ohms on electrode pair 12,14 as well as high impedances of greater than 4,000 ohms on some electrode pairs.Additionally, the patient experienced less than 50% therapy relief in the left hemibody.After the short was detected, programming was changed from bipolar stimulation to a double monopolar stimulation of c+, 4-, 5-.The other contacts on the lead were not therapeutic.The patient reportedly had some stimulation benefits, but the neurologist thought that the patient would be better with an intact system.The reporter indicated that the patient was deciding whether to have a revision in order to have a better clinical outcome.The patient was hesitating since the issue might be the lead and had to therefore consider a stereotactic intervention.

Manufacturer Narrative

Product id neu_unknown_ext, serial# unknown, implanted: 2014 (b)(6); product type extension product id 3389-40, lot# unknown, implanted: 2014 (b)(6); product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4686063
• MDR Text Key: 5690471
• Report Number: 9614453-2015-00995
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 04/13/2015
• Date Device Manufactured: 09/18/2013
• 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