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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number 37602
Device Problems Unintended Collision (1429); Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial#: (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that it was determined by the surgeon the patient had a short circuit.Patient fell hard on right side of head several months prior.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12413451
MDR Text Key269520520
Report Number3004209178-2021-13263
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169864207
UDI-Public00643169864207
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/02/2021
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 Date10/28/2019
Device Model Number37602
Device Catalogue Number37602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/11/2021
Initial Date FDA Received09/02/2021
Date Device Manufactured05/01/2018
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 Age66 YR
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