MAUDE Adverse Event Report: MEDTRONIC, INC. ACTIVA RC NEUROSTIMULATOR; DBS PULSE GENERATOR

Device Problems Low Battery (2584); Device Tipped Over (2589)

Patient Problem No Information (3190)

Event Date 01/14/2015

Event Type  Injury  

Event Description

Subject (b)(6) was seen on (b)(6) 2014 for study follow up with research team and pi.On (b)(6) 2014 night the battery was depleted.She tried to charge it but the battery had flipped on its own in her chest.She was unable to charge until she manually flipped the ipg herself and then she could charge it fully.There is no pain in the chest or any other complaints.The subject was scheduled for an outpatient surgical procedure to revise the left ipg anchorage.The physicians have elected to do this to ensure proper anchorage of the ipg.Of note is that all impedances are within normal limits and the device is working well at the time of the study follow up visit.Subject underwent an ipg revision (revision of the left chest wall pocket) on (b)(6) 2015.Battery was implanted and then the surgical procedure was closed in a standard fashion without complication.Electronic analysis of ipg was performed with programming to previous settings.Impedances were checked and were found to be within normal limits.Subject was sent home in a stable condition, and was scheduled for a follow up visit on (b)(6) 2015.Medtronic dbs lead kit model 3387 implanted on (b)(6) 2014 under id # (b)(4).

• Brand Name: ACTIVA RC NEUROSTIMULATOR
• Type of Device: DBS PULSE GENERATOR
• Manufacturer (Section D): MEDTRONIC, INC.; minneapolis MN
• MDR Report Key: 4442804
• MDR Text Key: 5379291
• Report Number: MW5040323
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 157