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

Model Number 37601

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Battery Problem (2885); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problems Edema (1820); Tingling (2171); Electric Shock (2554)

Event Date 04/29/2014

Event Type  Injury  

Event Description

Additional information received reported that there was an undesirable shocking sensation.It was noted that the ins was nearing end of life (eol).

Event Description

T was reported there were low impedances of 33 ohms on electrodes 0 and 1.The patient complained of tingling sensation down their right arm at different times.The tingling occurred sporadically and could be reproduced by palpating their chest where the stimulator was implanted.The stimulator was replaced.During the procedure it was clear there was fluid in the head portion of the stimulator.Additional information reported the patient was receiving therapy and had not reported any tingling sensation.It was reported the stimulator had been nearing end of life.It was also noted there was fluid around the pocket of the stimulator.The patient had been experiencing a shocking sensation when touching around the stimulator.The event was noted as resolved without sequelae and not related to the device or therapy and unlikely related to the implant procedure.

Manufacturer Narrative

Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # va0buyn, implanted: (b)(6) 2013, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v553425, implanted: (b)(6) 2010, product type lead.(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Manufacturer Narrative

Analysis of the ins found no significant anomalies.It was noted that the ins was functionally okay.It was noted that there were insignificant anomalies.

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: 3869958
• MDR Text Key: 4600966
• Report Number: 3004209178-2014-11493
• 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: Study,Health Professional,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2010
• 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): Required Intervention
• Patient Age: 00042 YR