MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problems Intermittent Continuity (1121); Low impedance (2285); Device Displays Incorrect Message (2591); Impedance Problem (2950)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare provider (hcp) reported impedance issues.It was stated that impedance measurements were taken, and that the impedance issues involve the right system, with the left body showing intermittency in therapy.The patient has a short between 0-1, opens involving 1-2 and 1-3, and case 0 has normal impedances.They have been programmed on c+1-2- for years and have done well.The short and opens have been reflected in impedances measurements since (b)(6)2015.It was further noted that in (b)(6) 2015 0-1 = 35 ohms, and as of a couple of weeks prior to date notified 0-1 = 79 ohms.In (b)(6) 2016 the opens and shorts were showing as well.Imaging done with the neurosurgeon recently has been negative.In 2015 the patient had a previously reported broken contact with the entire system being taken out as a result.More recently within the past week prior to date notified the patient was tackled by their friend, but the change in therapeutic benefit occurred prior to that event.The patient also has back pain with intermittency in therapeutic benefit within the last 2 weeks prior to date notified.The hcp is going to see the patient later on date notified.They are considering adding 0 to programming to see how well patient does, it may be added as a different group so the patient can switch back to current programming if desired.Indication for implant is dystonia and movement disorders.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) reported that when they were checking impedances all pairs with 1 are not > 40,000 ohms.The patient was programmed on c+ 0-1 and the therapy impedance was 582 ohms at 2.9ma, which was the same as last time.It was stated that the patient continues to have some pain and intermittency, and that the patient will be meeting with the surgeon next week and may have programming switched to c+ 0- to avoid 1.The patient's dystonia is still well controlled and the side with the impedance issues is not as significant as the other side controlling symptoms, as a result they will not aggressively troubleshoot this issue.

Manufacturer Narrative

(b)(4).

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5842728
• MDR Text Key: 51007902
• Report Number: 3004209178-2016-15424
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2016

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: 03/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/21/2016
• Supplement Dates FDA Received: 09/07/2016; 09/21/2016; 09/24/2017
• Date Device Manufactured: 09/29/2014
• 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