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

Model Number 3389S-40

Device Problems Bent (1059); Material Twisted/Bent (2981)

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

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was being implanted with an implantable neurostimulator (ins).It was reported the tip of the lead was bent during the test in the operation.Another new lead was used to complete the operation.The cause was unknown.The patient was in good condition and the issue resolved.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Country of origin is (b)(4).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.

Event Description

Additional information was received.The patient's date of birth was updated.The patient refused to tell their weight.The implant date of the lead was (b)(6) 2018.No further complications were reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the lead (lot no.Valmfck) found no anomaly.Analysis of the stylet wire found the wire was bent due to user error.(b)(4).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): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7642275
• MDR Text Key: 112556343
• Report Number: 6000153-2018-00014
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VALMFCK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 07/03/2018; 12/14/2018; 12/28/2018
• Supplement Dates FDA Received: 06/27/2018; 07/31/2018; 12/19/2018; 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 65 YR