MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems High impedance (1291); Low impedance (2285); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

It was reported that impedance issues were measured with the dystonia patient¿s implantable neurostimulator (ins) system.Impedance testing found a low impedance of 114 ohms between bipolar electrodes 4 and 7 of the right hemisphere.It was noted that the impedance value was ¿sometimes high¿ when the patient ¿pressed¿ the extension-lead connection.The patient was reportedly reprogrammed and underwent x-rays as a result of the event; however, the results were not indicated at the time of report.There were ¿no¿ patient symptoms or complications associated with the event and the patient was alive with no injury at the time of report.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant product: product id neu_unknown_ext, serial # unknown, product type extension; product id 3387, lot # unknown, product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4627380
• MDR Text Key: 5657061
• Report Number: 3004209178-2015-05270
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 03/24/2015
• Date Device Manufactured: 08/17/2011
• 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