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

Model Number 37612

Device Problems Energy Output To Patient Tissue Incorrect (1209); Pocket Stimulation (1463); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6).Information was received from a healthcare provider (hcp) and a consumer via the manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for depression and movement disorders.The rep reported that the patient was feeling parasthesia when pressing on the ins or recharging the ins.The rep reported that the parasthesia was not bothersome to the patient at this point.The rep reported that there had not been any falls or trauma related to the issue.The rep called back later to report that the patient didn't try to turn of the ins since there was not an hcp present.The rep reported that the patient first noticed the issues a few weeks after their implant.The rep reported that the patient always felt a tingling, there was just more when the device had pressure applied.The patient reported they typically pressed down hard on the recharger to locate the ins, but they did not have any problems getting coupling bars.The patient reported that the parasthesia felt like tingling behind the device.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).The rep reported that the parasthesia sensation went away when the therapy was turned off.The rep reported that the patient's impedances were checked and found to be fine.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• 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: 7404814
• MDR Text Key: 104836222
• Report Number: 3004209178-2018-06700
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169105492
• UDI-Public: 00643169105492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/26/2017
• 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 Age: 48 YR