MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Low impedance (2285)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va05agw, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va0a3a0, implanted: (b)(6) 2013, product type: lead.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.

Event Description

Information was received from a health care provider via a manufacturing representative regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.The manufacturing representative reported that impedances were measured to be low.Impedances were less than 50 ohms on electrode combination 0-3.The electrode pair with low impedances was not being used for programming.The patient's health care provider (hcp) had been programming around the shorts.No patient symptoms were reported.

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

Additional information was received from a manufacturer representative (rep).It was reported that the cause of the short had not been identified; the bipolar pair 0+3 had an impedance of 37ohms while all other pairs were within normal limits.Additionally, no falls or trauma was reported to be related to the issue.It was noted that the implantable neurostimulator (ins) was replaced as it had reached elective replacement indicator (eri).During the replacement surgery, the connection to the battery was inspected but appeared to be ok.The impedances were not resolved.

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): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5584132
• MDR Text Key: 42875694
• Report Number: 3004209178-2016-07626
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2016

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: 11/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided; 05/11/2016
• Supplement Dates FDA Received: 06/01/2016; 09/21/2017
• Date Device Manufactured: 05/31/2013
• 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