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

Model Number 37612

Device Problem Low impedance (2285)

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

Event Type  malfunction  

Event Description

It was reported that the patient¿s implantable neurostimulators (ins) were interrogated with the clinician programmer and both were on.The impedances were checked and all were normal, except one low impedance on the right ins.The electrode combination of 8 and 10 was 55 ohms.According to the office the impedance had been there for a long time and was programmed around.The cause of the low impedance was not determined.The results were satisfactory; the patient was well and receiving effective therapy.

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: 2011-(b)(6), product type: implantable neurostimulator.Product id: 37752, serial# (b)(4), product type: recharger.Product id: 748240, serial# (b)(4), implanted: 2003-(b)(6), product type: extension.Product id: neu_unknown_lead, serial# (b)(4), implanted: 2003-(b)(6), product type: lead.Product id: 3389-40, lot# j042 1661v, implanted: 2004-(b)(6), product type: lead.Product id: 748240, serial# (b)(4), implanted: 2004-(b)(6), product type: extension.(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: 4508228
• MDR Text Key: 5533204
• Report Number: 3004209178-2015-02836
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

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: 04/28/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/11/2015
• Date Device Manufactured: 06/03/2011
• 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