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

Model Number 37603

Device Problem Low impedance (2285)

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

Event Type  Injury  

Event Description

It was reported that low impedances of 20 ohms was measured on electrodes 8 and 10.The implantable neurostimulator (ins) and both extensions were replaced.The patient was not using those contacts for therapy.After the revision, the patient was doing fine and they were receiving effective therapy.

Manufacturer Narrative

Concomitant products: product id 37085-40, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type implantable neurostimulator; product id 37085-40, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 3387s-40, lot # v270501, implanted: (b)(6) 2009, product type lead product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 3387s-40, lot # v270501, implanted: (b)(6) 2009, product type lead; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type implantable neurostimulator.(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: 4798928
• MDR Text Key: 21800741
• Report Number: 3004209178-2015-09731
• 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: 05/06/2015

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: 08/28/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/27/2015
• Date Device Manufactured: 03/12/2012
• 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): Required Intervention