MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Edema (1820); Seizures (2063)

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported the patient had a complication of a seizure one month post-op with the mri showing significant edema and cyst formation around the left lead.At two month visit, the new mri showed the issue had resolved, but there was a similar process around the right lead.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.

Event Description

Additional review indicates this information was already reported in manufacturer¿s report #(b)(6).Any additional information regarding the event will be submitted as a supplemental submission to that report.

Manufacturer Narrative

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

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; sullivan lake
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; sullivan lake
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7694997
• MDR Text Key: 114203263
• Report Number: 3007566237-2018-02114
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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 Outcome(s): Other