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

Model Number 3387S-40

Device Problems Contamination (1120); Unintended Collision (1429); Device Damaged by Another Device (2915)

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

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins).The rep reported that during the stage 2 implant, the lead got stuck in the lead end cap, and somehow, made it past the setscrew block and got stuck in the rubber/plastic behind the setscrew block at the tip.The rep reported that the healthcare provider (hcp) tried to dissect the end cap to get the lead, but dropped the contact.The hcp reported that the patient needs constant future mris and so they didn't want to continue using the lead which might have been compromised.The consumer reported that the patient normally falls on the right side.The rep reported that the hcp implanted the left lead, but pulled the right lead.No patient symptoms were reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.

Event Description

The lead lot number was updated.The patient's weight remained unknown.The lead was removed and no hardware was left in on the right side.The surgeon and parent believed that the child may have had a fall after stage 1 and before stage 2 that could have caused the contact to get lodged into the lead end cap.

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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6559042
• MDR Text Key: 74917221
• Report Number: 3007566237-2017-01812
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/26/2017

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 Expiration Date: 10/11/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1EHTC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided; 05/11/2017; 05/11/2017
• Supplement Dates FDA Received: 05/26/2017; 10/04/2017; 10/04/2017
• Date Device Manufactured: 02/06/2017
• 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: 12 YR