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

Model Number 37612

Device Problems Low impedance (2285); Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are : product id: 7482a95, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: extension.Product id: 748295, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: extension.Other relevant device(s) are: product id: 7482a95, serial/lot #: (b)(4), ubd: (b)(6) 2011, udi#: (b)(4); product id: 748295, serial/lot #: (b)(4), ubd: (b)(6) 2011, udi#: (b)(4).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) for essential tremor.It was reported that has always had shorts, on contacts 5 and 7.Patient stated that they did not know if it was in the head implants or other connections.No patient symptoms were reported.Additional information received from a health care provider (hcp) on july 13th, 2018, indicating that the cause of the short circuit was probably the lead or extension.It was reported that on (b)(6), the extensions were removed and replaced, and the issue was resolved.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 from the manufacturer representative (rep) stating the extension was replaced on (b)(6) 2018.It was reported only the extension was replaced.The caller reported that c0 continued to show 2455 ohms.No symptoms were reported.

Manufacturer Narrative

Corrected information.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: 7700134
• MDR Text Key: 114364265
• Report Number: 3004209178-2018-16087
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 09/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 08/09/2018; 08/08/2018
• Supplement Dates FDA Received: 08/13/2018; 10/04/2018
• Date Device Manufactured: 11/02/2015
• 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: 67 YR
• Patient Weight: 91