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

Model Number 37603

Device Problems Break (1069); Intermittent Continuity (1121); Low impedance (2285); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3387s-40, lot# va14yzv, implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: va14yzv, (b)(6),(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative (rep) regarding a patient who was implanted with an im plantable neuro stimulator (ins) for movement disorders.It was reported that the patient was scheduled to have a battery replacement, and pre-op routine impedance check revealed a possible short.Upon investigating the connection during surgery, they noticed that the lead was damaged.The surgeon aborted the procedure, cut the damaged portion of the lead off and concluded that patient would need to come back to have the lead replaced, at which time the doctor will then also replace the left battery.The replacement case was to be scheduled.No replacements were done on the day of the report.It was also reported that patient had intermediate therapy.The issue was resolved at the time of the report.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 rep indicating that the left battery replacement was due to normal battery depletion per the doctor.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3387s-40 lot# va14yzv serial# implanted: 2016-(b)(6) explanted: product type lead : due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event: analysis of the lead lot # va14yzv found that the lead body conductor was broken within 10cm of connector area.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.

• 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: 7560713
• MDR Text Key: 109789297
• Report Number: 3004209178-2018-12362
• Device Sequence Number: 1
• Product Code: MHY
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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