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

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 11/30/2013

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: neu_unknown_lead, implanted: (b)(6) 2010, product type: lead.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 37651, serial# (b)(4), product type: recharger.

Event Description

The consumer whose indication for use is dystonia reported that the recharger was not charging.The metal connector pin broke and fell out.It was further reported that the patient's device was in a suspected overdischarge (od) on (b)(6) 2013.It was the first od.It was unknown if a physician mode recharge (pmr) was performed.The accompanying por was not cleared successfully.The device was unable to be charged with the recharger due to the broken recharger, the usb connector was broken.There was a cord issue.The patient was directed to their physician for troubleshooting.It was unknown if there were any patient symptoms.

Manufacturer Narrative

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

• 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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5666089
• MDR Text Key: 45481472
• Report Number: 3004209178-2016-09829
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: 02/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: 05/18/2016
• Supplement Dates FDA Received: 09/22/2017
• Date Device Manufactured: 03/26/2010
• 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: 29 YR