MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3387-40

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

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_ins_stimulator, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional of a clinical study (hcp) via a manufacturer representative (rep) regarding a patient implanted with a neurostimulator.It was reported that the tip of the electrode was bent prior to implant.As a result the lead was not implanted with another lead used instead.The issue was resolved at the time of the report.The patient status was alive - no injury and no further complications are anticipated.It was noted that the patient has a past medical history of a manganese transporter deficiency.

Manufacturer Narrative

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 received reported that the lead was bent out of box, with it noted that the patient wasn't involved in a clinical trial and was receiving a full system.No further complications are anticipated.

Manufacturer Narrative

Analysis of the lead kit 3387-40 quad 1.5mm sp dbs 40cm lot # 0214124308 confirmed that the distal end of the lead was bent.{ electrical testing of the lead determined that continuity was complete and no electrical shorts were observed between circuits.} electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7108188
• MDR Text Key: 94547731
• Report Number: 2649622-2017-15599
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: 3387-40
• Device Catalogue Number: 3387-40
• Device Lot Number: 0214124308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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: 20 YR