MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problem Low impedance (2285)

Patient Problem Scar Tissue (2060)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

It was reported that low impedances were measured.Impedances on contact pairs 8 and 9, 8 and 10, 8 and 11, 9 and 11, and 10 and 11 were 31 ohms.Impedances on contact pair 9 and 10 were 30 ohms.The lead and ins were still implanted.After the implantable neurostimulator (ins) was activated, impedances were still low but the patient was feeling better.The patient was able to walk and no longer had pain in the back.Impedances were measured at activation and found to only have increased by 6-8 ohms on each contact.Stimulation was increased to 4 v on the right side and no side effects were seen.A ct scan was planned for january to determine if there was an issue with the lead/extension.The scar on the right side of the patient¿s scalp had healed.The left side had not yet scarred but this was expected by the health care provider as the patient¿s skin scarred slowly on that side.

Manufacturer Narrative

Concomitant medical products: product id 3387, serial# unknown, implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4366534
• MDR Text Key: 5266973
• Report Number: 3004209178-2014-24601
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/04/2014

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: 08/14/2015
• 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: 12/04/2014
• Initial Date FDA Received: 12/29/2014
• Date Device Manufactured: 09/17/2014
• 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