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

Model Number 3389-28

Device Problems Bent (1059); Shipping Damage or Problem (1570)

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

Event Date 06/03/2015

Event Type  malfunction  

Event Description

It was reported that ¿when taking the lead out of the package the neurosurgeon realized that the tip of the lead was not straight.¿ it was stated there was ¿damage detected capping the lead.¿ the lead was not implanted as a result of the event.The lead was replaced as a result and the issue was resolved.The event did not involve a patient.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Manufacturer Narrative

Device analysis for lead 0209102077 revealed the proximal end insulation was broken under the connector.

Manufacturer Narrative

Conclusion code was updated.

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): 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: 4895674
• MDR Text Key: 15246269
• Report Number: 6000153-2015-00132
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2018
• Device Model Number: 3389-28
• Device Catalogue Number: 3389-28
• Device Lot Number: 0209102077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• 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