MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Low Battery (2584)

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

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3387s-40, lot# v049666, implanted: (b)(6) 2007, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.

Event Description

A manufacturer representative (rep) reported that a colleague saw the patient two weeks prior to date notified and their implant was at eri.It was stated that they are doing an implantable neurostimulator (ins) replacement on date notified, and checked the ins voltage which showed to be at 2.81v.The rep believes the patient probably left therapy on over the past two weeks prior to date notified and did not turn it off.Impedances were checked and the left side was fine but the right is showing a few low combinations as follows.Left side: 3+ 2- 1- 0+ 3.4v, 90 pw, 130 rate, 539 ohms, and right side: 6- 5- 4+ 3.4v, 90 pw, 130 rate, 210 ohms.The out of range electrodes are used in programming but the patient did not report any therapy concerns.Indication for implant is dystonia and movement disorders.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5994752
• MDR Text Key: 56339883
• Report Number: 3004209178-2016-20271
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Date Device Manufactured: 05/01/2015
• 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: 45 YR