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

Model Number 37603

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2013

Event Type  Injury  

Event Description

It was reported in (b)(6) 2013, the right side of the head had an infection and ¿frequent procedures¿ were provided.In (b)(6) 2014, the left side was implanted.The left lead had been placed running down the right side of the head and thus the infection extended to the left chest.In (b)(6) 2014, the entire right side system was explanted.The left lead was repositioned so that it ran down the left side of the head and the left extension and stimulator were also replaced with a new one.Hospitalization was required due to the event and the event was considered related to the lead and not to the stimulator.The patient¿s outcome was noted to be recovered.

Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown; product type lead product id 3387, serial# unknown; product type lead product id neu_ins_stimulator; product type implantable neurostimulator product id neu_unknown_lead; product type lead product id neu_unknown_ext; product type extension product id neu_unknown_ext; product type extension.(b)(4).

Manufacturer Narrative

Hospitalization was accidentally omitted from the original report.

Event Description

Additional information received reported there was a skin ulcer in left anterior thorax on (b)(6) 2014.On (b)(6) 2014 the left implantable neurostimulator (ins) was replaced and the wound was treated due to skin pressure from misalignment/displacement.The patient had required hospitalization or had to stay longer for treatment.The patient was discharged, healed.The outcome was recovered.This was related to the neurostimulator, but not the lead.Medical history included cerebral palsy.

Manufacturer Narrative

(b)(4).

Event Description

Additional information indicated the moved implantable neurostimulator (ins) compressed the skin tissue and as a result, the patient had a cutaneous ulcer.Patient's medical history included an active infection and active cutaneous ulcer.

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): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4394060
• MDR Text Key: 21941202
• Report Number: 3004209178-2015-00284
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 05/11/2016; 05/11/2016
• Supplement Dates FDA Received: 01/07/2015; 04/04/2016; 05/11/2016; 05/11/2016; 09/22/2017; 09/22/2017
• Date Device Manufactured: 10/12/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR