MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Low Battery (2584)

Patient Problem Electric Shock (2554)

Event Date 03/21/2013

Event Type  Injury  

Event Description

It was reported there was periodic shocking sensations extending from the patient¿s left parietal location down to their jaw.This only happened when the right brain lead was on even more so when they used contacts two and three together.A short circuit in the wiring was noted.Impedance was low between contact 2 and 3.The device was replaced and the event was considered resolved without sequelae.Information on shocking and short circuit was originally reported in manufacturer report #¿s 3004209178-2012-12357 and 3004209178-2012-12352.

Manufacturer Narrative

Concomitant: product id 3387s-40, lot# va04pwk, implanted: 2012-(b)(6), product type lead.Product id 37602, serial# (b)(4), implanted: 2012-(b)(6), explanted: 2013-(b)(6), product type implantable neurostimulator.Product id 748251, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension.Product id 3387s-40, lot# va048wb, implanted: 2012-(b)(6), product type lead.Product id 748295, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information indicated the extension removal was an "elective choice".

Manufacturer Narrative

Evaluation codes updated to reflect changes to imdrf coding.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from an hcp of a clinical study indicated the patient's extension was replaced on (b)(6) 2013.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 4638973
• MDR Text Key: 5602369
• Report Number: 3004209178-2015-05564
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2020
• Date Device Manufactured: 06/27/2012
• 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
• Patient Age: 00050 YR