• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8549885
MDR Text Key143077712
Report Number3004209178-2019-08263
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169529786
UDI-Public00643169529786
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
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 Date09/14/2018
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/23/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received05/18/2019
05/18/2019
09/04/2019
10/29/2019
Supplement Dates FDA Received05/23/2019
05/23/2019
09/05/2019
11/01/2019
Date Device Manufactured03/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight107
-
-