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

Model Number 37601

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3708640, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for essential tremors, movement disorders.It was reported that there was high impedance during the procedure.Another extension was opened and had normal impedance so that one was implanted.The brain electrode impedance was checked and there was no issue.Either the extension was bad or a bad connection at the ipg, or a bad connection at the lead/extension.The issue was resolved.There were no symptoms.There were no further complications reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3708640, serial# (b)(4), product type: extension.Analysis revealed that the extension passed all tests and had shown no anomalies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the cause of the high impedances was unknown and the extension was returned for analysis.There were no further complications reported.

• 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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7542079
• MDR Text Key: 109499162
• Report Number: 3004209178-2018-11823
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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: 01/14/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2010
• 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 Age: 76 YR