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

Model Number 37612

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2021

Event Type  Injury  

Event Description

It was reported that the wire behind the patient's ear got disconnected and the hcp revised the system a year ago.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, serial# unknown, implanted: (b)(6) 2011, product type lead.Product id 37085-60, serial# unknown, implanted: (b)(6) 2011, product type extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: unknown.Product id: 37085-60, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, serial# unknown, implanted: (b)(6) 2011, product type lead.Product id 37085-60, serial# unknown, implanted: (b)(6) 2011, product type extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: unknown.Product id: 37085-60, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the wire behind the patient's ear got disconnected and the hcp revised the system a year ago.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13481416
• MDR Text Key: 285251851
• Report Number: 3004209178-2022-01739
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• Date Device Manufactured: 09/19/2016
• 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: 68 YR
• Patient Sex: Male