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

Model Number 3387S-40

Device Problems Break (1069); Peeled/Delaminated (1454)

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

Event Date 08/05/2019

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 consumer regarding a patient who was implanted with a neurostimulator (ins).It was reported that the outer sheath separated from the contacts on the distal end of the lead.Caller stated they didn't notice the issue out of box but when physician was gently pulling back the outer guide tube, physician noticed the issue.Therefore, the caller was unsure if the lead was damaged out of the box or not.A different lead was used without issue and there was no patient injury.The caller had the lead in their possession.No symptoms were reported.No further complications were reported or anticipated with this event.

Manufacturer Narrative

Analysis of the lead (lot# va20mmm) revealed the insulation was torn under the connector at the proximal end.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the reason for the damage was undetermined.The rep.Requested the appropriate return mailer kit and would be returning it as soon as the mailing kit arrived.No patient symptoms or further complications were anticipated.

• 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
• MDR Report Key: 8875874
• MDR Text Key: 153960219
• Report Number: 3007566237-2019-01728
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2022
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA20MMM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 95