MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA IMPLANTABLE EXTENSION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7482A51

Device Problems Unintended Collision (1429); Low impedance (2285); Impedance Problem (2950)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant product: product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator.(b)(4).

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the right implantable neurostimulator (ins) voltage was at 2.93v but is reading end of service (eos) and stimulation cannot be turned on.The patient was programmed with 0-2+ and has a history of normal impedance measurements; (b)(6) 2015: 618 ohms, (b)(6) 2015: 652 ohms, (b)(6) 2015: 1530 ohms, (b)(6) 2016 (eos): 1199 ohms.The patient was scheduled for surgery on (b)(6) 2016 to have the right ins and extension replaced.Follow-up revealed that health care provider (hcp) was surprised that the ins moved quickly to eos and is suspicious that there is an electrical short at, or near, the ins as there was a surprising change in the patient's impedances on the right side a few months ago.The hcp noted the patient has not experienced any clinical worsening as there is a delayed therapeutic benefit in dystonia.It was also reported that the patient fell in (b)(6) 2015.An x-ray was performed revealed there were no fractures.If additional information is received, a follow-up report will be submitted.Please see report number 3004209178-2016-03820.

Event Description

Additional information received from the manufacturer representative (rep) reported that the right implantable neurostimulator (ins) was replaced.It was reviewed that the ins was showing end of service (eos) but the ins battery was at 2.91 volts.The physician thought it was the right extension that had a fracture, but when the impedance was interrogated, all values were normal and therefore the physician concluded it was an ins issue.It was reviewed that an x-ray had been done and showed no anomalies.It was unknown if palpation was done during impedance testing and it was unknown if taping of the ins was done to check for battery bouncing.

• Brand Name: ACTIVA IMPLANTABLE EXTENSION
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5476632
• MDR Text Key: 39561963
• Report Number: 6000153-2016-00698
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

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: 10/22/2012
• Device Model Number: 7482A51
• Device Catalogue Number: 7482A51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Date Device Manufactured: 10/22/2008
• 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: 00064 YR