MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Complaint, Ill-Defined (2331)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of the event: (b)(6) 2018 is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that since the car accident in 2018, the ins battery unit was eroding out of the patient's chest about a third of the way out and the surgeon believes it started when they had the accident because the seatbelt pushed against it, it's been eroding since the accident.Patient stated they saw the surgeon on monday and was going to the hospital tomorrow morning so they can remove the stimulator and lead wires but they won't touch the electrodes.Patient stated that the health care professional (hcp) is going to have put on antibiotics overnight after the surgery and has already started patient on oral antibiotics in case there is an infection on the implant site.Patient stated that implant site does not really hurt much, it just looks gross and it was kind of nagging.Patient mentioned that obviously this was because of the accident and there was no liability for the manufacturer.Patient noted that they will be without the device a while implant site heals before they can get a replacement.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that much of the same information was reiterating, but the patient stated the seat belt crushed against their ins causing it to "migrate" out of their chest and the reason why they had their previous ins replaced.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received from the consumer reported the explant of the device and leads on (b)(6) 2019 resolved the issue, but there were serious infections in their body that required intravenous antibiotics.No further complications were anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reporting that the patient had a new ins put in and they were looking for a longevity estimate: amp: 3.5v 90us 185hz 1244ohms amp: 4.5v 120us 185hz 1100ohms estimated time eri: 17.2 months eos: 20.2 months they reiterated the infection and explant that occurred in (b)(6) 2019.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8549885
• MDR Text Key: 143077712
• Report Number: 3004209178-2019-08263
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/01/2019

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: 09/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/18/2019; 05/18/2019; 09/04/2019; 10/29/2019
• Supplement Dates FDA Received: 05/23/2019; 05/23/2019; 09/05/2019; 11/01/2019
• Date Device Manufactured: 03/24/2017
• 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: 72 YR
• Patient Weight: 107