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

Model Number 37612

Device Problems Break (1069); Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problems Twitching (2172); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with a neurostimulator for dystonia.It was reported that while watching tv, therapy stopped working because of the occurrence of a power on reset (por) message; the por was successfully cleared and therapy was turned back on.The patient confirmed that his device had a 50% charge and there were no electrical fields, magnets, or falls/trauma that could have influenced the device; the patient did not know what caused the por.It was also noted that a couple of months ago, the patient's implantable neurostimulator (ins) overdischarged but it was successfully recovered by the health care provider (hcp); another overdischarged occurred a few years ago.The patient reported that his arms were twitching and twisting, and that therapy hasn't been helping much for the past 5 months.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2016, product type: extension.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2016, product type: extension.

Event Description

Additional information received reported the cause of the overdischarge was due to failure of the extension lead.There was separation of the outer shell, exposing the lead ailments.This was clearly visible on x-ray.Replacement surgery was pending.

Event Description

Additional information was received from a health care provider (hcp).It was reported that the cause of the overdischarges was the splitting of the silicone sleeve of the lead's extension.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 5700741
• MDR Text Key: 46599197
• Report Number: 3004209178-2016-10895
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Date Device Manufactured: 02/17/2011
• 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: 49 YR